Company ยท US
Protek, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 1989. Name variants (Inc, Corp, punctuation) are merged.
25510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 7 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 4 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 3 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 2 |
| MBV | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer | 2 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 |
| JDR | Staple, Fixation, Bone | 1 |
| KWM | Prosthesis, Wrist, Semi-Constrained | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 1 |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 9, 1989 | K893785 | ARC-2F ACETABULAR CUP Protek, Inc. | LWJ |
| Jul 25, 1989 | K893959 | P.S.A. FEMORAL HIP PROSTHESIS Protek, Inc. | KWY |
| Jul 19, 1989 | K892059 | FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR Protek, Inc. | LZY |
| May 26, 1989 | K883794 | RESUBMITTED CLW ACETABULAR CUP W/SULMESH Protek, Inc. | LWJ |
| May 10, 1989 | K884952 | VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC Protek, Inc. | LZO |
| Feb 27, 1989 | K884889 | MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP. Protek, Inc. | KWL |
| Feb 8, 1989 | K890054 | M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI. Protek, Inc. | JDI |
| Feb 8, 1989 | K884789 | NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI Protek, Inc. | KWL |
| Dec 29, 1988 | K884888 | MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS Protek, Inc. | JDI |
| Oct 20, 1988 | K882671 | SAMUELSON SCREWLOC CUP Protek, Inc. | KWA |
| Jan 27, 1988 | K874093 | SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP Protek, Inc. | JDI |
| Oct 28, 1987 | K873429 | FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE Protek, Inc. | MBV |
| Oct 28, 1987 | K870922 | C.L.E. ACETABULAR CUP Protek, Inc. | JDI |
| Oct 1, 1987 | K872985 | SAMUELSON ACETABULAR CUP Protek, Inc. | KWA |
| Sep 14, 1987 | K870924 | CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT. Protek, Inc. | KWA |
| Sep 14, 1987 | K870923 | SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX. Protek, Inc. | KWA |
| Jul 23, 1987 | K872502 | M.W.P. WRIST PROSTHESIS Protek, Inc. | KWM |
| Jul 1, 1987 | K871347 | WAGNER REVISIONAL FEMORAL HIP PROSTHESIS Protek, Inc. | JDI |
| Feb 11, 1987 | K861988 | MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY Protek, Inc. | JDI |
| Aug 7, 1986 | K862752 | C.S.M. HIP Protek, Inc. | |
| Feb 18, 1986 | K853730 | FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP Protek, Inc. | MBV |
| Nov 19, 1985 | K853768 | MULLER SELF LOCKING TOTAL HIP Protek, Inc. | JDI |
| Sep 24, 1985 | K853662 | MUELLER CURVED STEM HEMI-PROSTHESIS Protek, Inc. | KWL |
| Sep 6, 1985 | K853267 | DAY STAPLE Protek, Inc. | JDR |
| Sep 4, 1985 | K853268 | FREEMAN UNI-COMPARTMENTAL KNEE Protek, Inc. | HSX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||