MICRO-STRUC. ACETABULAR COMPON- MC2P

Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Micro-struc. Acetabular Compon- Mc2p.

Pre-market Notification Details

• Device ID: K850352
• 510k Number: K850352
• Device Name: MICRO-STRUC. ACETABULAR COMPON- MC2P
• Classification: Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
• Applicant: OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677
• Contact: Dennis H Crane
• Correspondent: Dennis H Crane; OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677
• Product Code: JDL
• CFR Regulation Number: 888.3320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-01-28
• Decision Date: 1985-04-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327021400	K850352	000
07613327021554	K850352	000
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07613327038200	K850352	000