Opus Medical, Inc.
Albuquerque, NM, US
Opus Medical, Inc. appears in FDA device records in Albuquerque, NM. FDA records list 13 510(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
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Opus Medical, Inc. between 2001 and 2004. The busiest year on record is 2003, with 5. The most recent is 2004, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 2 |
| 2002 | 2 |
| 2003 | 5 |
| 2004 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K042584 | OPUS MINIMAGNUM ANCHOR WITH INSERTER | HWC | Substantially Equivalent | |
| K042914 | OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE | MBI | Substantially Equivalent | |
| K042031 | OPUS SPEEDSTITCH SUTURE DEVICE | GAT | Substantially Equivalent | |
| K041440 | OPUS MAGNUM ANCHOR WITH INSERTER | MBI | Substantially Equivalent | |
| K033317 | SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070 | OCW | Substantially Equivalent | |
| K030170 | REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 | OCW | Substantially Equivalent | |
| K031083 | OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500 | HTY | Substantially Equivalent | |
| K030235 | F1 DIODE LASER SYSTEM | GEX | Substantially Equivalent | |
| K023843 | SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE | OCW | Substantially Equivalent | |
| K022229 | SMARTSTITCH SUTURE DEVICE, MODEL OM-8500 | OCW | Substantially Equivalent | |
| K020172 | OPUS MAGNUM ANCHOR & INSTRUMENT SET | MBI | Substantially Equivalent | |
| K012125 | OPUS MAGNUM ANCHOR & INSERTER | HTY | Substantially Equivalent | |
| K004021 | F1 DIODE LASER SYSTEM | GEX | 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