The following data is part of a premarket notification filed by Synthes Spine Co.lp with the FDA for Synthes Pangea Monoaxial System.
| Device ID | K052151 |
| 510k Number | K052151 |
| Device Name: | SYNTHES PANGEA MONOAXIAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Angela Mikroulis |
| Correspondent | Angela Mikroulis SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-08 |
| Decision Date | 2005-12-07 |
| Summary: | summary |