The following data is part of a premarket notification filed by Medtronic with the FDA for Cd Horizon Spinal System.
| Device ID | K211596 |
| 510k Number | K211596 |
| Device Name: | CD Horizon Spinal System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Medtronic 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Diamond Wallace |
| Correspondent | Diamond Wallace Medtronic 1800 Pyramid Place Memphis, TN 38132 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-24 |
| Decision Date | 2021-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000352097 | K211596 | 000 |
| 00763000351960 | K211596 | 000 |
| 00763000351953 | K211596 | 000 |
| 00763000351946 | K211596 | 000 |
| 00763000351939 | K211596 | 000 |
| 00763000351922 | K211596 | 000 |
| 00763000351892 | K211596 | 000 |
| 00763000351885 | K211596 | 000 |
| 00763000352011 | K211596 | 000 |
| 00763000351977 | K211596 | 000 |
| 00763000351984 | K211596 | 000 |
| 00763000352080 | K211596 | 000 |
| 00763000352073 | K211596 | 000 |
| 00763000352066 | K211596 | 000 |
| 00763000352059 | K211596 | 000 |
| 00763000352042 | K211596 | 000 |
| 00763000352035 | K211596 | 000 |
| 00763000352004 | K211596 | 000 |
| 00763000351991 | K211596 | 000 |
| 00763000352028 | K211596 | 000 |