BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

ENDOTEC, INC.

The following data is part of a premarket notification filed by Endotec, Inc. with the FDA for Buechel-pappas Extended Collar Femoral Stem Prosth.

Pre-market Notification Details

• Device ID: K905262
• 510k Number: K905262
• Device Name: BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: ENDOTEC, INC. 20 VALLEY ST. South Orange, NJ 07079
• Contact: Michael J Pappas
• Correspondent: Michael J Pappas; ENDOTEC, INC. 20 VALLEY ST. South Orange, NJ 07079
• Product Code: JDI
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-11-23
• Decision Date: 1993-05-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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