OSTEONICS 7000 POSTERIOR STAB. TOTAL KNEE FEM. COM

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics 7000 Posterior Stab. Total Knee Fem. Com.

Pre-market Notification Details

• Device ID: K914565
• 510k Number: K914565
• Device Name: OSTEONICS 7000 POSTERIOR STAB. TOTAL KNEE FEM. COM
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677
• Contact: Robert Koch
• Correspondent: Robert Koch; OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-10-15
• Decision Date: 1992-05-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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