PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM— 510(k) K123207

Substantially Equivalent

Osteomed LP

FDA 510(k) clearance K123207 for PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM, Substantially Equivalent on 2012-11-29. Applicant: Osteomed LP.

Clearance details

Applicant: Osteomed LP
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2012-10-12
Decision date: 2012-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Addison, 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.