Device Classification Name: filler, bone void, calcium compound 510(k) Number: K102722: Device Name: NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY

NORIAN® Drillable Inject, OSTEOSET® CATEGORIZATION CHARACTERISTICS REGULATORY PATHWAY AND CLINICAL BURDEN OF PROOF EXAMPLES. Recombinant Growth Factors Allograft . Tissue Scaffolds. With the myriad of bone graft options available and continuing to grow, it has become increasingly difficult for surgeons and hospitals to avoid confusion and

Norian®. Remodeling Characteristics of Arthrex Quickset™ Preclinical Studies Comparing Arthrex Quickset™ vs. Norian SRS. File Type: Ref. #: LA1-00014-EN   HydroSet vs. Norian. Which will you choose? Norian CRS Fast Set Putty Technique Guide.

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NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY. Device Classification Name: filler, bone void, calcium compound 510(k) Number: K102722: Device Name: NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY: Applicant: SYNTHES USA PRODUCTS LLC: 1230 wilson drive: west chester, PA : 19380 . For contraindications of Norian Drillable or chronOS Inject see the corresponding technique guides (Norian Drillable 036.000.757, chronOS Inject 036.000.794). Indications and Contraindications LCP Proximal Tibial Plate 3.5 Technique Guide Synthes 5 Retiro De Equipo (Recall) de Device Recall Norian Drillable Injects Sterile Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Synthes (USA) Products LLC. NORIAN® Drillable Inject, OSTEOSET® CATEGORIZATION CHARACTERISTICS REGULATORY PATHWAY AND CLINICAL BURDEN OF PROOF EXAMPLES Recombinant Growth Factors Allograft Tissue Synthetic Scaffolds Grafting Options Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process.

9665, NORIAN DRILLABLE INJECT 10CC, $ 31,229.62. 9666, NORIAN DRILLABLE INJECT 5CC, $ 15,890.69. 9667, nortriptyline 10 mg capsule 1 each BLIST 

As a bone substitute, two common clinically used calcium phosphate cements, Norian® Drillable and ChronOS™ Inject, were During testing, ChronOS™ inject exhibited a fixed contact with the synthetic bone spongiosa whereas Norian® Drillable was pressed out of the application channel. During maximal load testing of the Norian® Drillable group, the lateral tibial plateau stayed intact, whereas in the ChronOS™ inject group, the lateral tibial plateau broke completely away.

when drilled. Norian drillable (DePuy Synthes, West Chester, PA) was developed to circumvent this concern–as FDA approved product for drilling, it offers the ability to inject calcium phosphate into the void before implantation of fixation. A recent publication investigated articular subsidence between

Two screws, 4 screws and a lateral buttress plate were investigated. As a bone substitute, two common clinically used calcium phosphate cements, Norian® Drillable and ChronOS™ Inject, were New SYNTHES 07.704.010S Norian Drivable Inject (X) 07.704.010S Disposables - General For Sale - DOTmed Listing #2917470: SYNTHES Norian Rotary Mixer MXR-US-2000 Norian SRS Rotary Mix On August 15, 2017 an Urgent Medical Device Recall notice, titled "895204 NORIAN DRILLABLE INJECT" was issued to customers instructing them to review inventory and quarantine all affected product subject to the recall.

96376 27008235 NORIAN DRILLABLE INJECT 5CC. 278 OP. 4,362.45. $. 2780, 21400521, NORIAN DRILLABLE INJECT 10CC, 13,788.00. 2781, 21400522, WRIGHT MED 4.5 CANULATED DRILL, 931.00.
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Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S Intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. Code Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S || Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure. On August 15, 2017 an Urgent Medical Device Recall notice, titled "895204 NORIAN DRILLABLE INJECT" was issued to customers instructing them to review inventory and quarantine all affected product subject to the recall. For questions. concerns or to obtain a return authorization Call 1-800-479-6329.

After reduction the specimens were randomly divided into eight different groups of stabilization (Table 1).Three osteosyntheses, 2 screws, 4 screws in the jail technique and a lateral angle stable L-buttress plate, were tested alone (Fig. 2) and in combination with two commonly used bone substitutes, ChronOS™ inject and Norian® Drillable (Synthes GmbH, Umkirch, Germany). Norian Drillable Inject Norian Drillable.
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Norian Drillable Inject SRS FAST SET PUTTY 3 CC BONE VOID FILLERSTERILE. Model / Serial Part Number SRS-005-FSP, Lot number N001101 Product

For questions. concerns or to obtain a return authorization Call 1-800-479-6329. Returned product will be credited. Norian Drillable Inject SRS FAST SET PUTTY 3 CC BONE VOID FILLERSTERILE. Model / Serial Part Number SRS-005-FSP, Lot number N001101 Product 2021-04-05 · NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY: Applicant: SYNTHES USA PRODUCTS LLC: 1230 WILSON DRIVE: west chester, PA 19380 Applicant Description. Norian® Drillable Norian® Drillable is a biocompatible1, fiber reinforced calcium phosphate bone void filler that is intended to be placed into bony voids or defects of the extremities and pelvis either before or after final fixation.

Description Norian® Drillable Norian® Drillable is a biocompatible1, fiber reinforced calcium phosphate bone void filler that is intended to be placed into bony voids or defects of the extremities and pelvis either before or after final fixation.

Indications and Contraindications LCP Proximal Tibial Plate 3.5 Technique Guide Synthes 5 Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process.

Substantial Documentation is provided that demonstrates that Norian Equivalence: Drillable is substantially equivalent4 to other legally marketed devices. Norian drillable (DePuy Synthes, West Chester, PA) was developed to circumvent this concern–as FDA approved product for drilling, it offers the ability to inject calcium phosphate into the void before implantation of fixation. ments: ChronOS™ inject is a ß-tricalcium phosphate bone substitute, whereas Norian® Drillable is a fiber reinforced calcium phosphate bone filler. After fracture stabilization, the specimens were examined using x-rays to assess the fracture reduction and the position of the osteosyntheses and the bone substitute.