K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage— 510(k) K212038

Substantially Equivalent

K&J Consulting Corporation

FDA 510(k) clearance K212038 for K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage, Substantially Equivalent on 2021-08-27. Applicant: K&J Consulting Corporation.

Clearance details

Applicant: K&J Consulting Corporation
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2021-06-30
Decision date: 2021-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lansdale, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.