Medicrea International SA: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Medicrea International SA” (first 2015, latest 2022), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 149 days. Since 2017 the median was 137 days, against 88 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
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 4 | 210 |
| 2016 | 7 | 125 |
| 2017 | 3 | 114 |
| 2018 | 3 | 133 |
| 2019 | 4 | 147 |
| 2020 | 1 | 266 |
| 2021 | 1 | 198 |
| 2022 | 2 | 141 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medicrea International SA took a median 137 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 8 | 8 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 6 | 6 |
| OWI | Bone Fixation Cerclage, Sublaminar | 4 | 4 |
| NKG | Posterior Cervical Screw System | 3 | 3 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
Review panels
- Orthopedic (25)
Most recent Medicrea International SA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213659 | LigaPASS 2.0 Ligament Augmentation System | OWI | 2022-05-24 | 186 |
| K213281 | PASS LP Spinal System, CD Horizon Spinal System | NKB | 2022-01-05 | 96 |
| K210470 | C-CURVE Interbody Fusion Device | OVE | 2021-09-03 | 198 |
| K200316 | UNiD IB3D ALIF | MAX | 2020-10-30 | 266 |
| K191134 | IB3D ALIF | MAX | 2019-10-30 | 184 |
| K182158 | UNiD Patient-matched PLIF cage | MAX | 2019-07-15 | 340 |
| K190092 | UNiD Patient specific 3D printed TLIF cage | MAX | 2019-05-08 | 110 |
| K190376 | PASS LP Spinal System | NKB | 2019-05-02 | 72 |
| K182240 | PASS LP Spinal System | NKB | 2018-10-17 | 58 |
| K173782 | UNiD Patient Specific 3D printed cage | MAX | 2018-04-25 | 133 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medicrea International SA.
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.
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 (18 510(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 SA?
FDA lists 25 510(k) clearances under the applicant name “Medicrea International SA” (first 2015, latest 2022), across 8 product codes in 1 review panel. 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 SA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medicrea International SA is 149 days. Since 2017: 137 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medicrea International SA?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 8); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 6); OWI (Bone Fixation Cerclage, Sublaminar, 4).
Next steps
- See all 25 Medicrea International SA clearances with predicates and recalls
- Run predicate analysis for product code NKB, Medicrea International SA'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.