Medicrea International: FDA filings under this applicant name

FDA lists 18 510(k) clearances under the applicant name “Medicrea International” (first 2011, latest 2022), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 106 days. Since 2017 the median was 29 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Medicrea International took a median 29 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.

Top product codes

Plus 1 more product codes.

Review panels

• Orthopedic (15)
• Radiology (3)

Most recent Medicrea International 510(k) clearances

8 earlier clearances. See the full list in Caduvo.

Recalls

22 product recalls in 9 recall events; 14 initiated in the last five years. Most recent: 2025-10-29.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Medicrea International is the lead sponsor of 6 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT04547959: Prospective Clinical Study to Evaluate the Efficacy of the Stand-alone Cervical Interbody Cage C-CURVE ( Titanium) Manufactured by MEDICREA® (Completed, started 2020-11-20)
• NCT04670536: The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems (PASS DEGEN) (Completed, started 2018-05-17)
• NCT02931279: PASS OCT® Post-market Clinical Follow-up (Completed, started 2016-10)
• NCT02926391: UNiD 3D VBR Register (Completed, started 2016-10)
• NCT01518582: GRANVIA®-C Cervical Disc Prosthesis Multicenter European Pilot Study (Completed, started 2012-08)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Medicrea International SA (25 510(k)s)
• Medicrea Technologies (14 510(k)s)
• Medicrea (4 510(k)s)
• Medicrea International S.A.S. (Medtronic) (4 510(k)s)
• Medicrea International S.A.S (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Medicrea International?

FDA lists 18 510(k) clearances under the applicant name “Medicrea International” (first 2011, latest 2022), across 11 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Medicrea International?

The median time from FDA receipt to decision across 510(k)s cleared under the name Medicrea International is 106 days. Since 2017: 29 days, versus 90 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Medicrea International?

The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 3); MNI (Orthosis, Spinal Pedicle Fixation, 3); OSH (Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis, 3).

Next steps

• See all 18 Medicrea International clearances with predicates and recalls
• Run predicate analysis for product code LLZ, Medicrea International's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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