The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Pediatric Mandible Distractor.
| Device ID | K133398 |
| 510k Number | K133398 |
| Device Name: | STRYKER PEDIATRIC MANDIBLE DISTRACTOR |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | Stryker 750 TRADE CENTRE WAY STE 200 Portage, MI 49002 |
| Contact | Manish Patel |
| Correspondent | Manish Patel Stryker 750 TRADE CENTRE WAY STE 200 Portage, MI 49002 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-06 |
| Decision Date | 2014-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613252634416 | K133398 | 000 |
| 07613252634409 | K133398 | 000 |
| 07613252634393 | K133398 | 000 |
| 07613252634386 | K133398 | 000 |
| 07613252634379 | K133398 | 000 |
| 07613252634362 | K133398 | 000 |
| 07613252634355 | K133398 | 000 |
| 07613252634348 | K133398 | 000 |