The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Relieve Laminoplasty Fixation System.
| Device ID | K080664 |
| 510k Number | K080664 |
| Device Name: | RELIEVE LAMINOPLASTY FIXATION SYSTEM |
| Classification | Orthosis, Spine, Plate, Laminoplasty, Metal |
| 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 | NQW |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-10 |
| Decision Date | 2008-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889095040760 | K080664 | 000 |
| 00889095040616 | K080664 | 000 |
| 00889095040609 | K080664 | 000 |
| 00889095040593 | K080664 | 000 |
| 00889095215366 | K080664 | 000 |
| 00889095215359 | K080664 | 000 |
| 00889095215342 | K080664 | 000 |
| 00889095215335 | K080664 | 000 |
| 00889095215328 | K080664 | 000 |
| 00889095215311 | K080664 | 000 |
| 00889095215304 | K080664 | 000 |
| 00889095215298 | K080664 | 000 |
| 00889095215281 | K080664 | 000 |
| 00889095040623 | K080664 | 000 |
| 00889095040630 | K080664 | 000 |
| 00889095040753 | K080664 | 000 |
| 00889095040746 | K080664 | 000 |
| 00889095040739 | K080664 | 000 |
| 00889095040722 | K080664 | 000 |
| 00889095040715 | K080664 | 000 |
| 00889095040708 | K080664 | 000 |
| 00889095040692 | K080664 | 000 |
| 00889095040685 | K080664 | 000 |
| 00889095040678 | K080664 | 000 |
| 00889095040661 | K080664 | 000 |
| 00889095040654 | K080664 | 000 |
| 00889095040647 | K080664 | 000 |
| 00889095215274 | K080664 | 000 |