The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Total Performance (tps) System.
| Device ID | K032117 |
| 510k Number | K032117 |
| Device Name: | STRYKER TOTAL PERFORMANCE (TPS) SYSTEM |
| Classification | Drill, Bone, Powered |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Jean W Sheppard |
| Correspondent | Jean W Sheppard STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | DZI |
| Subsequent Product Code | EIA |
| Subsequent Product Code | ERL |
| Subsequent Product Code | GEY |
| Subsequent Product Code | HBC |
| Subsequent Product Code | HBE |
| Subsequent Product Code | HSZ |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-09 |
| Decision Date | 2003-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327174892 | K032117 | 000 |
| 04546540970275 | K032117 | 000 |
| 04546540494740 | K032117 | 000 |
| 04546540401724 | K032117 | 000 |
| 04546540391810 | K032117 | 000 |
| 04546540391803 | K032117 | 000 |
| 04546540384959 | K032117 | 000 |
| 04546540384942 | K032117 | 000 |
| 04546540380289 | K032117 | 000 |
| 04546540380272 | K032117 | 000 |
| 04546540075734 | K032117 | 000 |
| 34546540075728 | K032117 | 000 |
| 34546540075711 | K032117 | 000 |
| 04546540075703 | K032117 | 000 |
| 04546540075222 | K032117 | 000 |
| 04546540074768 | K032117 | 000 |
| 04546540971272 | K032117 | 000 |
| 04546540977748 | K032117 | 000 |
| 04546540983930 | K032117 | 000 |
| 37613327117050 | K032117 | 000 |
| 37613327117043 | K032117 | 000 |
| 37613327117036 | K032117 | 000 |
| 07613327116557 | K032117 | 000 |
| 07613327116540 | K032117 | 000 |
| 07613327116496 | K032117 | 000 |
| 07613327116489 | K032117 | 000 |
| 07613327116472 | K032117 | 000 |
| 07613327116465 | K032117 | 000 |
| 07613327116441 | K032117 | 000 |
| 07613327116434 | K032117 | 000 |
| 07613153100379 | K032117 | 000 |
| 04546540991720 | K032117 | 000 |
| 34546540991691 | K032117 | 000 |
| 04546540991676 | K032117 | 000 |
| 04546540074393 | K032117 | 000 |