The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Adapt For Gamma3, Gamma3.
| Device ID | K181848 |
| 510k Number | K181848 |
| Device Name: | ADAPT For Gamma3, Gamma3 |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Stryker GMBH 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Tina Mornak |
| Correspondent | Tina Mornak Stryker GMBH 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-11 |
| Decision Date | 2018-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327312430 | K181848 | 000 |
| 07613327312393 | K181848 | 000 |