B-P HEMISPHERICAL ACETABULAR COMPONENT

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

ENDOTEC, INC.

The following data is part of a premarket notification filed by Endotec, Inc. with the FDA for B-p Hemispherical Acetabular Component.

Pre-market Notification Details

• Device ID: K963101
• 510k Number: K963101
• Device Name: B-P HEMISPHERICAL ACETABULAR COMPONENT
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: ENDOTEC, INC. 20 VALLEY ST. South Orange, NJ 07079
• Contact: Michael Pappas, Ph.d., Pe
• Correspondent: Michael Pappas, Ph.d., Pe; ENDOTEC, INC. 20 VALLEY ST. South Orange, NJ 07079
• Product Code: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-08-09
• Decision Date: 1997-02-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00814193022448	K963101	000
00814193022592	K963101	000
00814193022608	K963101	000
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00814193022639	K963101	000
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00814193022677	K963101	000
00814193022684	K963101	000
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00814193022578	K963101	000
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00814193022479	K963101	000
00814193022486	K963101	000
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00814193022707	K963101	000
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00814193022851	K963101	000
00814193022844	K963101	000
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00814193022721	K963101	000
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00814193022745	K963101	000
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