The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Cd Horizon Spinal System.
| Device ID | K132471 |
| 510k Number | K132471 |
| Device Name: | CD HORIZON SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Sowmya Shetty |
| Correspondent | Sowmya Shetty MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-07 |
| Decision Date | 2013-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169354197 | K132471 | 000 |
| 00643169348066 | K132471 | 000 |
| 00643169348059 | K132471 | 000 |
| 00643169348042 | K132471 | 000 |
| 00643169348035 | K132471 | 000 |
| 00643169348028 | K132471 | 000 |
| 00643169348011 | K132471 | 000 |
| 00643169348004 | K132471 | 000 |
| 00643169347991 | K132471 | 000 |
| 00643169347984 | K132471 | 000 |
| 00643169347977 | K132471 | 000 |
| 00643169347960 | K132471 | 000 |
| 00643169347953 | K132471 | 000 |
| 00643169347946 | K132471 | 000 |
| 00643169348073 | K132471 | 000 |
| 00643169348080 | K132471 | 000 |
| 00643169348097 | K132471 | 000 |
| 00643169348226 | K132471 | 000 |
| 00643169348219 | K132471 | 000 |
| 00643169348202 | K132471 | 000 |
| 00643169348196 | K132471 | 000 |
| 00643169348189 | K132471 | 000 |
| 00643169348172 | K132471 | 000 |
| 00643169348165 | K132471 | 000 |
| 00643169348158 | K132471 | 000 |
| 00643169348141 | K132471 | 000 |
| 00643169348134 | K132471 | 000 |
| 00643169348127 | K132471 | 000 |
| 00643169348110 | K132471 | 000 |
| 00643169348103 | K132471 | 000 |
| 00643169347939 | K132471 | 000 |