The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Navigation Instruments.
| Device ID | K153203 |
| 510k Number | K153203 |
| Device Name: | Navigation Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVENUE Audubon, PA 19403 |
| Contact | Kelly J Baker |
| Correspondent | Kelly J Baker GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVENUE 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 | 2015-11-04 |
| Decision Date | 2016-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889095174038 | K153203 | 000 |
| 00889095173864 | K153203 | 000 |
| 00889095173871 | K153203 | 000 |
| 00889095173888 | K153203 | 000 |
| 00889095173895 | K153203 | 000 |
| 00889095173901 | K153203 | 000 |
| 00889095173932 | K153203 | 000 |
| 00889095173949 | K153203 | 000 |
| 00889095173956 | K153203 | 000 |
| 00889095173963 | K153203 | 000 |
| 00889095173970 | K153203 | 000 |
| 00889095174045 | K153203 | 000 |
| 00889095174052 | K153203 | 000 |
| 00889095174069 | K153203 | 000 |
| 00889095174137 | K153203 | 000 |
| 00889095173819 | K153203 | 000 |
| 00889095173840 | K153203 | 000 |
| 00889095173857 | K153203 | 000 |