OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS

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 Omnifit Total Knee Series Ii Tibial Inserts.

Pre-market Notification Details

• Device ID: K884398
• 510k Number: K884398
• Device Name: OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677
• Contact: Michael B Sheldon
• Correspondent: Michael B Sheldon; OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-10-19
• Decision Date: 1989-01-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327034288	K884398	000
07613327034097	K884398	000
07613327034080	K884398	000
07613327034073	K884398	000
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07613327034059	K884398	000
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07613327033946	K884398	000