IMPIX MANTA CERVICAL INTERBODY DEVICE— 510(k) K100484

Clearance details

Applicant

Medicrea

Product code

Code ODP

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2010-02-18

Decision date

2010-03-16

Decision

Substantially Equivalent

Clearance type

Special

Location

Round Rock, TX, US

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• K254130 — C.A. Medical Interbody Fusion System2026-07-08

• K062136 — PASS 2 SPINAL SYSTEM2006-10-06
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• K032094 — PASSMED SPINAL SYSTEM2003-11-14

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 →

• Z-2456-2023 — IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i) B20181953, j) B20181963, k) B20181973, l) B20182253, m) B20182263; 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 K100484.