FDA Device Intelligence
Home › ALPHATEC SPINE, INC. › Arsenal

Arsenal

ALPHATEC SPINE, INC. · Model 48500-065-035 · UDI-DI 00840967164366

OSHMNIMNHKWPNKB Prescription
1
510(k) clearances
106
Adverse events
1
Recalls
158
Facilities

Description

CLOSED POLYAXIAL SCREW, 6.5mm X 35mm

Recalls

DateFirmReason
2017-08-03OrthoPediatrics CorpThe 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data 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.