IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF— 510(k) K083798

Clearance details

Applicant

Medicrea Technologies

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2008-12-22

Decision date

2010-05-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Douglassville, PA, US

• K261049 — SCALA® TL2026-08-20
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• K261020 — Symmetrix L Spinal System2026-07-14
• K253420 — Admiral ACP System +18 more2026-07-01

• K102406 — PASS ANTERIOR SPINAL SYSTEM2011-08-23
• K100544 — IMPIX LUMBAR INTERBODY DEVICE2010-07-22
• K100297 — PASS LP SPINAL SYSTEM2010-03-04
• K083810 — PASS LP SPINAL SYSTEM2009-07-31
• K083308 — PASS LP SPINAL SYSTEM2008-12-10

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 →

• Z-2453-2023 — IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbarClass II·Ongoing·Medicrea International·20230712
• Z-2457-2023 — IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; intervertebral fusion device - lumbarClass II·Ongoing·Medicrea International·20230712

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083798.