The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Revere Sacral Plates.
| Device ID | K103072 |
| 510k Number | K103072 |
| Device Name: | REVERE SACRAL PLATES |
| 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 | KWP |
| Subsequent Product Code | KWQ |
| 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 | 2010-10-18 |
| Decision Date | 2011-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849044067323 | K103072 | 000 |
| 00849044066609 | K103072 | 000 |
| 00849044066593 | K103072 | 000 |
| 00849044066586 | K103072 | 000 |
| 00849044066579 | K103072 | 000 |
| 00849044066562 | K103072 | 000 |
| 00849044066555 | K103072 | 000 |
| 00849044066548 | K103072 | 000 |
| 00849044066531 | K103072 | 000 |
| 00849044066524 | K103072 | 000 |
| 00849044066517 | K103072 | 000 |
| 00889095047189 | K103072 | 000 |
| 00889095047172 | K103072 | 000 |
| 00889095047165 | K103072 | 000 |
| 00889095046557 | K103072 | 000 |
| 00889095046540 | K103072 | 000 |
| 00889095046533 | K103072 | 000 |
| 00849044066616 | K103072 | 000 |
| 00849044067149 | K103072 | 000 |
| 00849044067156 | K103072 | 000 |
| 00849044067316 | K103072 | 000 |
| 00849044067309 | K103072 | 000 |
| 00849044067293 | K103072 | 000 |
| 00849044067286 | K103072 | 000 |
| 00849044067279 | K103072 | 000 |
| 00849044067262 | K103072 | 000 |
| 00849044067255 | K103072 | 000 |
| 00849044067248 | K103072 | 000 |
| 00849044067231 | K103072 | 000 |
| 00849044067224 | K103072 | 000 |
| 00849044067217 | K103072 | 000 |
| 00849044067200 | K103072 | 000 |
| 00849044067194 | K103072 | 000 |
| 00849044067187 | K103072 | 000 |
| 00849044067170 | K103072 | 000 |
| 00849044067163 | K103072 | 000 |
| 00889095046526 | K103072 | 000 |