K221646 is an FDA 510(k) clearance for the CD HORIZON? ASTUTE? SPINAL SYSTEM; CD HORIZON? Growth Rod Conversion Set; CD HORIZON? SPINAL SYSTEM; CD Horizon? Fenestrated Screw Set; COLORADO 2? SPINAL System; GDLH? POSTERIOR SPINAL SYSTEM; SHILLA? Growth Guidance System; TENOR? SPINAL SYSTEM. This device is classified as a Thoracolumbosacral Pedicle Screw System (Class II - Special Controls, product code NKB).
Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on October 4, 2022, 120 days after receiving the submission on June 6, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070. Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion..
| 510(k) Number | K221646 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2022 |
| Decision Date | October 04, 2022 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | NKB — Thoracolumbosacral Pedicle Screw System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |
| Definition | Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion. |