STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF)— 510(k) K102322

Substantially Equivalent

Omni Surgical, L.P.

FDA 510(k) clearance K102322 for STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF), Substantially Equivalent on 2011-01-07. Applicant: Omni Surgical, L.P..

Clearance details

Applicant: Omni Surgical, L.P.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2010-08-17
Decision date: 2011-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Rock, TX, US

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Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.