Medicrea International
Medicrea International holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2022, with 22 FDA device recalls on record.
Top product codes for Medicrea International
FDA recalls by Medicrea International
10 most recent of 22- Z-1039-2026 — Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
- Z-1038-2026 — Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
- Z-1118-2025 — UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display, store data needed for planning a spine surgery or for post-operative follow-up (patient information, X-ray image and recommendations for planning). The UNiD Spine Analyzer cloud based software is a healthcare application intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries.
- Z-2459-2023 — GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A13131789, f)¿¿¿¿¿¿ A13132012, g)¿¿¿¿¿ B13111014, h)¿¿¿¿ B13111015, i)¿¿¿¿¿¿ B13111016, j)¿¿¿¿¿¿ B13111017, k)¿¿¿¿¿ B13111025, l)¿¿¿¿¿¿ B13111026, m)¿¿¿ B13111027, n)¿¿¿¿ B13111034, o)¿¿¿¿ B13111035, p)¿¿¿¿ B13111036; intervertebral fusion device - cervical
- Z-2462-2023 — IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B20171963, h) B20171973, i) B20172253, j) B20172263, k) B20172273; intervertebral fusion device - cervical
- Z-2461-2023 — IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical
- Z-2458-2023 — PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B02317550Z; intervertebral fusion device - cervical
- Z-2454-2023 — IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar
- 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 - lumbar
- 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 - lumbar
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Medicrea International
- K220810 — Infinity OCT System and PASS OCT Spinal System
- K220724 — CD Horizon Spinal System and PASS LP Spinal System
- K180091 — UNiD Spine Analyzer
- K170172 — UNiD Spine Analyzer
- K153169 — PASS OCT Patient Specific Rods
- K150049 — PASS LP Spinal System
- K140738 — PASS LP SPINAL SYSTEM
- K133906 — C-JAWS CERVICAL COMPRESSIVE STAPLE
- K132395 — LIGAPASS
- K132574 — PASS LP SPINAL SYSTEM
- K132575 — PASS LP SPINAL SYSTEM
- K121979 — PASS OCT SPINAL SYSTEM
- K123138 — PASS LP SPINAL SYSTEM
- K121323 — MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE
- K112736 — PASS LP SPINAL
- K112493 — PASS LP SPINAL SYSTEM
- K110497 — PASS LP SPINAL SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.