Medicrea Technologies: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Medicrea Technologies” (first 2007, latest 2011), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 134 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | 6 | 6 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 2 | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
Review panels
- Orthopedic (14)
Most recent Medicrea Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102406 | PASS ANTERIOR SPINAL SYSTEM | KWQ | 2011-08-23 | 364 |
| K100544 | IMPIX LUMBAR INTERBODY DEVICE | MAX | 2010-07-22 | 147 |
| K083798 | IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF | MAX | 2010-05-19 | 513 |
| K100297 | PASS LP SPINAL SYSTEM | MNI | 2010-03-04 | 30 |
| K083810 | PASS LP SPINAL SYSTEM | MNI | 2009-07-31 | 221 |
| K083308 | PASS LP SPINAL SYSTEM | MNI | 2008-12-10 | 30 |
| K082577 | PASS LP SPINAL SYSTEM | MNH | 2008-10-03 | 28 |
| K082069 | PASS 2 SPINAL SYSTEM | MNI | 2008-10-03 | 73 |
| K080099 | PASS SPINAL SYSTEM | MNI | 2008-04-09 | 86 |
| K072226 | IMPIX SPACER | MAX | 2007-12-10 | 122 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medicrea Technologies.
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 SA (25 510(k)s)
- Medicrea International (18 510(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 Technologies?
FDA lists 14 510(k) clearances under the applicant name “Medicrea Technologies” (first 2007, latest 2011), across 5 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 Technologies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medicrea Technologies is 134 days.
Which FDA product codes appear under Medicrea Technologies?
The most frequent FDA product codes under this applicant name are MNI (Orthosis, Spinal Pedicle Fixation, 6); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 3); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2).
Next steps
- See all 14 Medicrea Technologies clearances with predicates and recalls
- Run predicate analysis for product code MNI, Medicrea Technologies'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.