The following data is part of a premarket notification filed by Stryker with the FDA for Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem.
| Device ID | K220731 |
| 510k Number | K220731 |
| Device Name: | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | Stryker 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Gregg Ritter |
| Correspondent | Gregg Ritter Stryker 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 |
| Subsequent Product Code | MAY |
| Subsequent Product Code | MBL |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-14 |
| Decision Date | 2022-08-11 |