Protek, Inc.
Medical device manufacturer in Indianapolis, IN.
25510(k) clearances
0PMA approvals
0recalls
Device types
- JDI Prosthesis, Hip, Semi-Constrained… 7
- KWA Prosthesis, Hip, Semi-Constrained (Metal… 4
- KWL Prosthesis, Hip, Hemi-, Femoral, Metal 3
- MBV Prosthesis, Knee, Patello/Femorotibial… 2
- LWJ Prosthesis, Hip, Semi-Constrained… 2
- HSX Prosthesis, Knee, Femorotibial… 1
- JDR Staple, Fixation, Bone 1
- KWM Prosthesis, Wrist, Semi-Constrained 1
- LZO Prosthesis, Hip, Semi-Constrained… 1
- LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball 1
- KWY Prosthesis, Hip, Hemi-, Femoral… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K893785 | ARC-2F Acetabular CupLWJ · Traditional | 08/09/1989SN |
| K893959 | P.S.A. Femoral Hip ProsthesisKWY · Traditional | 07/25/1989SE |
| K892059 | Femoral Heads/Modular & Fixed W/ Titan Nitride SurLZY · Traditional | 07/19/1989SE |
| K883794 | Resubmitted CLW Acetabular Cup W/SulmeshLWJ · Traditional | 05/26/1989SE |
| K884952 | Various Femoral Hip Prostheses W/Self Lock CeramicLZO · Traditional | 05/10/1989SE |
| K884889 | Modified O.E.C. Univ. Self-Aligning Aceta. Comp.KWL · Traditional | 02/27/1989SE |
| K890054 | M.E.M. Acetabular Cup W/Sulmesh for Cement Appli.JDI · Traditional | 02/08/1989SN |
| K884789 | New Jersey Femoral Hip Prosthesis for Cement AppliKWL · Traditional | 02/08/1989SN |
| K884888 | Modified New Jersey Acetabular Comp. & Bone ScrewsJDI · Traditional | 12/29/1988SN |
| K882671 | Samuelson Screwloc CupKWA · Traditional | 10/20/1988SE |
| K874093 | SLS-88 Total Hip System, Acetabular CupJDI · Traditional | 01/27/1988SE |
| K873429 | Freeman-Samuelson Mark II Press-Fit Total KneeMBV · Traditional | 10/28/1987SE |
| K870922 | C.L.E. Acetabular CupJDI · Traditional | 10/28/1987SE |
| K872985 | Samuelson Acetabular CupKWA · Traditional | 10/01/1987SE |
| K870924 | CLX Acetabular Cup (Wagner) for Cementless Fixat.KWA · Traditional | 09/14/1987SE |
| K870923 | Schuster Acetabular Cup for Cement/Cementless Fix.KWA · Traditional | 09/14/1987SE |
| K872502 | M.W.P. Wrist ProsthesisKWM · Traditional | 07/23/1987SE |
| K871347 | Wagner Revisional Femoral Hip ProsthesisJDI · Traditional | 07/01/1987SE |
| K861988 | Modified Protasul 100 (TI-6A1-7NB) AlloyJDI · Traditional | 02/11/1987SE |
| K862752 | C.S.M. Hip · Traditional | 08/07/1986SE |
| K853730 | Freeman-Samuelson Mark II Press-Fit Total Knee RepMBV · Traditional | 02/18/1986SE |
| K853768 | Muller Self Locking Total HipJDI · Traditional | 11/19/1985SE |
| K853662 | Mueller Curved Stem Hemi-ProsthesisKWL · Traditional | 09/24/1985SE |
| K853267 | Day StapleJDR · Traditional | 09/06/1985SN |
| K853268 | Freeman Uni-Compartmental KneeHSX · Traditional | 09/04/1985SE |