Orthofab, Inc.
Cottage Grove, MN, US
Orthofab, Inc. appears in FDA device records in Cottage Grove, MN. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 7
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 7 510(k) clearances for Orthofab, Inc. between 1985 and 1997. The busiest year on record is 1995, with 2. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1986 | 1 |
| 1988 | 1 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K962565 | POWERED WHEELCHAIR | ITI | Substantially Equivalent | |
| K952675 | ORTHOFAB WHEELCHAIR | ITI | Substantially Equivalent | |
| K950904 | ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR) | IOR | Substantially Equivalent | |
| K950903 | ORTHOFAB WHEELCHAIR ULTIMA (RIGID FRAME MANUAL WHEELCHAIR) | IOR | Substantially Equivalent | |
| K884812 | KARMA-RS, KARMA-FS WHEELCHAIRS | ITI | Substantially Equivalent | |
| K860095 | DIGIKIT NONPNEUMATIC TOURNIQUET | KCY | Substantially Equivalent | |
| K852661 | APOLLO STERILE BLADES | GES | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain