The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Patriot Transcontinental M Spacers.
| Device ID | K102313 |
| 510k Number | K102313 |
| Device Name: | PATRIOT TRANSCONTINENTAL M SPACERS |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon, PA 19403 |
| Contact | Kelly J Baker |
| Correspondent | Kelly J Baker GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon, PA 19403 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-16 |
| Decision Date | 2010-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849044038835 | K102313 | 000 |
| 00849044038828 | K102313 | 000 |
| 00849044038811 | K102313 | 000 |
| 00849044038804 | K102313 | 000 |
| 00849044038798 | K102313 | 000 |
| 00849044038781 | K102313 | 000 |