The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Omnifit M-ha Hip Stem Series.
| Device ID | K920231 |
| 510k Number | K920231 |
| Device Name: | OMNIFIT M-HA HIP STEM SERIES |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | STRYKER CORP. 59 ROUTE 17 Allendale, NJ 07401 |
| Contact | Robert A Koch |
| Correspondent | Robert A Koch STRYKER CORP. 59 ROUTE 17 Allendale, NJ 07401 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-17 |
| Decision Date | 1992-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327038347 | K920231 | 000 |
| 07613327038330 | K920231 | 000 |
| 07613327022506 | K920231 | 000 |
| 07613153324065 | K920231 | 000 |
| 07613153324058 | K920231 | 000 |
| 07613153324041 | K920231 | 000 |
| 07613153324034 | K920231 | 000 |
| 07613153324027 | K920231 | 000 |
| 07613153324010 | K920231 | 000 |