MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.

Prosthesis, Hip, Hemi-, Femoral, Metal

PROTEK, INC.

The following data is part of a premarket notification filed by Protek, Inc. with the FDA for Modified O.e.c. Univ. Self-aligning Aceta. Comp..

Pre-market Notification Details

• Device ID: K884889
• 510k Number: K884889
• Device Name: MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.
• Classification: Prosthesis, Hip, Hemi-, Femoral, Metal
• Applicant: PROTEK, INC. 5780 WEST 71ST ST. Indianapolis, IN 46278
• Contact: Kenneth Epling
• Correspondent: Kenneth Epling; PROTEK, INC. 5780 WEST 71ST ST. Indianapolis, IN 46278
• Product Code: KWL
• CFR Regulation Number: 888.3360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-11-22
• Decision Date: 1989-02-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00814193025975	K884889	000
00814193026132	K884889	000
00814193026149	K884889	000
00814193026156	K884889	000
00814193026163	K884889	000
00814193023292	K884889	000
00814193023308	K884889	000
00814193023315	K884889	000
00814193023322	K884889	000
00814193023339	K884889	000
00814193023346	K884889	000
00814193023353	K884889	000
00814193023360	K884889	000
00814193023377	K884889	000
00814193026125	K884889	000
00814193026118	K884889	000
00814193025982	K884889	000
00814193025999	K884889	000
00814193026002	K884889	000
00814193026019	K884889	000
00814193026026	K884889	000
00814193026033	K884889	000
00814193026040	K884889	000
00814193026057	K884889	000
00814193026064	K884889	000
00814193026071	K884889	000
00814193026088	K884889	000
00814193026095	K884889	000
00814193026101	K884889	000
00814193023384	K884889	000
00814193023391	K884889	000
00814193023551	K884889	000
00814193023568	K884889	000
00814193023575	K884889	000
00814193023582	K884889	000
00814193023599	K884889	000
00814193023605	K884889	000
00814193023612	K884889	000
00814193023629	K884889	000
00814193023636	K884889	000
00814193023643	K884889	000
00814193023650	K884889	000
00814193023667	K884889	000
00814193023674	K884889	000
00814193023544	K884889	000
00814193023537	K884889	000
00814193023407	K884889	000
00814193023414	K884889	000
00814193023421	K884889	000
00814193023438	K884889	000
00814193023445	K884889	000
00814193023452	K884889	000
00814193023469	K884889	000
00814193023476	K884889	000
00814193023483	K884889	000
00814193023490	K884889	000
00814193023506	K884889	000
00814193023513	K884889	000
00814193023520	K884889	000
00814193023681	K884889	000