The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Navigation Instruments.
| Device ID | K180690 |
| 510k Number | K180690 |
| Device Name: | Navigation Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
| Contact | Lori Burns |
| Correspondent | Lori Burns Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-16 |
| Decision Date | 2018-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889095717235 | K180690 | 000 |
| 00889095717228 | K180690 | 000 |
| 00889095717211 | K180690 | 000 |
| 00889095717204 | K180690 | 000 |
| 00889095717198 | K180690 | 000 |
| 00889095717181 | K180690 | 000 |