Integrum AB: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Integrum AB”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PJY | Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees | 1 | 0 |
Review panels
- Orthopedic (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P190009 | PMA | OPRA Implant System | 2020-12-18 |
Recalls
openFDA lists no recalls under a recalling firm named Integrum AB.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Integrum AB?
FDA lists 0 510(k) clearances under the applicant name “Integrum AB”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Integrum AB?
The most frequent FDA product codes under this applicant name are PJY (Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees, 1).
Next steps
- See all 0 Integrum AB clearances with predicates and recalls
- Run predicate analysis for product code PJY, Integrum AB'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.