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CD HORIZON® Spinal System
MEDTRONIC SOFAMOR DANEK, INC. · Model X0812201 · UDI-DI 00643169372191
1
510(k) clearances
106
Adverse events
1
Recalls
158
Facilities
Description
SCR X0812201 SOL 5.5/6.0 RED UAS 8.5X50
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-08-03 | OrthoPediatrics Corp | The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.