Protek, Inc.
Indianapolis, IN, US
Protek, Inc. appears in FDA device records in Indianapolis, IN. FDA records list 25 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 25
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 25 510(k) clearances for Protek, Inc. between 1985 and 1989. The busiest year on record is 1987, with 8. The most recent is 1989, with 8.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 4 |
| 1986 | 2 |
| 1987 | 8 |
| 1988 | 3 |
| 1989 | 8 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K893785 | ARC-2F ACETABULAR CUP | LWJ | Substantially Equivalent for Some Indications | |
| K893959 | P.S.A. FEMORAL HIP PROSTHESIS | KWY | Substantially Equivalent | |
| K892059 | FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR | LZY | Substantially Equivalent | |
| K883794 | RESUBMITTED CLW ACETABULAR CUP W/SULMESH | LWJ | Substantially Equivalent | |
| K884952 | VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC | LZO | Substantially Equivalent | |
| K884889 | MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP. | KWL | Substantially Equivalent | |
| K890054 | M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI. | JDI | Substantially Equivalent for Some Indications | |
| K884789 | NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI | KWL | Substantially Equivalent for Some Indications | |
| K884888 | MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS | JDI | Substantially Equivalent for Some Indications | |
| K882671 | SAMUELSON SCREWLOC CUP | KWA | Substantially Equivalent | |
| K874093 | SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP | JDI | Substantially Equivalent | |
| K873429 | FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE | MBV | Substantially Equivalent | |
| K870922 | C.L.E. ACETABULAR CUP | JDI | Substantially Equivalent | |
| K872985 | SAMUELSON ACETABULAR CUP | KWA | Substantially Equivalent | |
| K870924 | CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT. | KWA | Substantially Equivalent | |
| K870923 | SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX. | KWA | Substantially Equivalent | |
| K872502 | M.W.P. WRIST PROSTHESIS | KWM | Substantially Equivalent | |
| K871347 | WAGNER REVISIONAL FEMORAL HIP PROSTHESIS | JDI | Substantially Equivalent | |
| K861988 | MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY | JDI | Substantially Equivalent | |
| K862752 | C.S.M. HIP | Substantially Equivalent | ||
| K853730 | FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP | MBV | Substantially Equivalent | |
| K853768 | MULLER SELF LOCKING TOTAL HIP | JDI | Substantially Equivalent | |
| K853662 | MUELLER CURVED STEM HEMI-PROSTHESIS | KWL | Substantially Equivalent | |
| K853267 | DAY STAPLE | JDR | Substantially Equivalent for Some Indications | |
| K853268 | FREEMAN UNI-COMPARTMENTAL KNEE | HSX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- LZYProsthesis, Hip, Hemi-, Femoral, Metal Ball
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- MBVProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
- KWMProsthesis, Wrist, Semi-Constrained
- JDRStaple, Fixation, Bone
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain