The following data is part of a premarket notification filed by Stryker Orthopaedics with the FDA for Insignia Hip Stem.
| Device ID | K211703 |
| 510k Number | K211703 |
| Device Name: | Insignia Hip Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Valerie Giambanco |
| Correspondent | Gregg Ritter Howmedica Osteonics Corp Aka Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | MEH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-03 |
| Decision Date | 2021-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327520033 | K211703 | 000 |
| 07613327511550 | K211703 | 000 |
| 07613327511543 | K211703 | 000 |
| 07613327511536 | K211703 | 000 |
| 07613327511529 | K211703 | 000 |
| 07613327511512 | K211703 | 000 |
| 07613327511505 | K211703 | 000 |
| 07613327511499 | K211703 | 000 |
| 07613327511482 | K211703 | 000 |
| 07613327511475 | K211703 | 000 |
| 07613327511468 | K211703 | 000 |
| 07613327511451 | K211703 | 000 |
| 07613327511444 | K211703 | 000 |
| 07613327511437 | K211703 | 000 |
| 07613327511420 | K211703 | 000 |
| 07613327511413 | K211703 | 000 |
| 07613327511406 | K211703 | 000 |
| 07613327511567 | K211703 | 000 |
| 07613327511574 | K211703 | 000 |
| 07613327520026 | K211703 | 000 |
| 07613327520019 | K211703 | 000 |
| 07613327520002 | K211703 | 000 |
| 07613327519990 | K211703 | 000 |
| 07613327519983 | K211703 | 000 |
| 07613327519976 | K211703 | 000 |
| 07613327519969 | K211703 | 000 |
| 07613327519952 | K211703 | 000 |
| 07613327519945 | K211703 | 000 |
| 07613327519921 | K211703 | 000 |
| 07613327519907 | K211703 | 000 |
| 07613327511628 | K211703 | 000 |
| 07613327511611 | K211703 | 000 |
| 07613327511604 | K211703 | 000 |
| 07613327511598 | K211703 | 000 |
| 07613327511581 | K211703 | 000 |
| 07613327511390 | K211703 | 000 |