The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Pediatric Mandibular Distractor 2.
| Device ID | K181504 |
| 510k Number | K181504 |
| Device Name: | Stryker Pediatric Mandibular Distractor 2 |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | Stryker 750 Trade Centre Way - Suite 200 Portage, MI 49002 |
| Contact | Gregory Gohl |
| Correspondent | Gregory Gohl Stryker 750 Trade Centre Way - Suite 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 | 2018-06-07 |
| Decision Date | 2018-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327294378 | K181504 | 000 |
| 07613327504408 | K181504 | 000 |
| 07613327504415 | K181504 | 000 |
| 07613327291315 | K181504 | 000 |
| 07613327291322 | K181504 | 000 |
| 07613327291339 | K181504 | 000 |
| 07613327291346 | K181504 | 000 |
| 07613327291353 | K181504 | 000 |
| 07613327291377 | K181504 | 000 |
| 07613327291384 | K181504 | 000 |
| 07613327291391 | K181504 | 000 |
| 07613327294361 | K181504 | 000 |
| 07613327520293 | K181504 | 000 |