Orthomatrix, Inc.
Collierville, TN, US
Orthomatrix, Inc. appears in FDA device records in Collierville, TN. FDA records list 8 510(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
- 8
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 8 510(k) clearances for Orthomatrix, Inc. between 1984 and 2001. The busiest year on record is 1985, with 3. The most recent is 2001, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1985 | 3 |
| 2000 | 3 |
| 2001 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K010738 | CANNULATED PLUS SCREW SYSTEM | HWC | Substantially Equivalent | |
| K001254 | ORTHOMATRIX, INC. CERCLAGE SYSTEM | JDQ | Substantially Equivalent | |
| K992856 | MAGELLAN HUMERAL INTRAMEDULLARY NAIL | HSB | Substantially Equivalent | |
| K992850 | MAGELLAN TIBIAL INTRAMEDULLARY NAIL | HSB | Substantially Equivalent | |
| K852766 | HA-1000 & HA-500 HYDROXYLAPATITE TOOTH ROOT SUBSTI | LYC | Substantially Equivalent | |
| K852765 | HA-2000 HYDROXYLAPATITE | LYC | Substantially Equivalent | |
| K851367 | HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION | DZE | Substantially Equivalent | |
| K842163 | RIDGEMATRIX 20/40 MESH, PERIOMATRIX | LYC | 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