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Response 5.5/6.0 Spine System
ORTHOPEDIATRICS CORP. · Model 00-1350-0635 · UDI-DI 00841132137635
10
510(k) clearances
106
Adverse events
1
Recalls
158
Facilities
Description
5.5/6.0 UNIAXIAL SINGLE LEAD PEDICLE SCREWS - Ø6.0MM, 35MM LENGTH
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.