The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Tsrh Spinal System.
| Device ID | K103049 |
| 510k Number | K103049 |
| Device Name: | TSRH SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Lila Joe |
| Correspondent | Lila Joe MEDTRONIC SOFAMOR DANEK 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 |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-15 |
| Decision Date | 2010-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994790101 | K103049 | 000 |
| 00613994789938 | K103049 | 000 |
| 00613994789945 | K103049 | 000 |
| 00613994789952 | K103049 | 000 |
| 00613994789969 | K103049 | 000 |
| 00613994789976 | K103049 | 000 |
| 00613994789983 | K103049 | 000 |
| 00613994789990 | K103049 | 000 |
| 00613994790002 | K103049 | 000 |
| 00613994790019 | K103049 | 000 |
| 00613994790026 | K103049 | 000 |
| 00613994790033 | K103049 | 000 |
| 00613994790040 | K103049 | 000 |
| 00613994790057 | K103049 | 000 |
| 00613994790064 | K103049 | 000 |
| 00613994790071 | K103049 | 000 |
| 00613994790088 | K103049 | 000 |
| 00613994790095 | K103049 | 000 |
| 00613994789921 | K103049 | 000 |