The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for H-link Integrated Rod.
| Device ID | K073517 |
| 510k Number | K073517 |
| Device Name: | H-LINK INTEGRATED ROD |
| Classification | Thoracolumbosacral Pedicle Screw System |
| 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 | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-14 |
| Decision Date | 2008-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849044049770 | K073517 | 000 |
| 00849044023251 | K073517 | 000 |
| 00849044023244 | K073517 | 000 |
| 00849044023237 | K073517 | 000 |
| 00849044023220 | K073517 | 000 |
| 00849044023213 | K073517 | 000 |
| 00849044023206 | K073517 | 000 |
| 00849044023190 | K073517 | 000 |
| 00849044023183 | K073517 | 000 |
| 00849044023268 | K073517 | 000 |
| 00849044023275 | K073517 | 000 |
| 00849044023282 | K073517 | 000 |
| 00849044049763 | K073517 | 000 |
| 00849044049756 | K073517 | 000 |
| 00849044023343 | K073517 | 000 |
| 00849044023336 | K073517 | 000 |
| 00849044023329 | K073517 | 000 |
| 00849044023312 | K073517 | 000 |
| 00849044023305 | K073517 | 000 |
| 00849044023299 | K073517 | 000 |
| 00849044023176 | K073517 | 000 |