The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Temporary Condylar Prosthesis.
| Device ID | K133285 |
| 510k Number | K133285 |
| Device Name: | STRYKER TEMPORARY CONDYLAR PROSTHESIS |
| Classification | Prosthesis, Condyle, Mandibular, Temporary |
| Applicant | Stryker 750 TRADE CENTRE WAY STE 200 Portage, MI 49002 |
| Contact | Jamshed Badarpura |
| Correspondent | Jamshed Badarpura Stryker 750 TRADE CENTRE WAY STE 200 Portage, MI 49002 |
| Product Code | NEI |
| CFR Regulation Number | 872.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-25 |
| Decision Date | 2014-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540374004 | K133285 | 000 |
| 04546540373991 | K133285 | 000 |
| 34546540373985 | K133285 | 000 |
| 07613327572087 | K133285 | 000 |