Opus Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 13
What Opus Medical, Inc. makes
Opus Medical, Inc. manufactures surgical anchors and suture devices, including knotless anchors like the OPUS MAGNUM KNOTLESS ANCHOR and the OPUS SPEEDSTITCH SUTURE DEVICE, designed for tissue fixation. Their portfolio also includes diode laser systems, such as the F1 DIODE LASER SYSTEM, and reusable suture devices like the SMARTSTITCH M-CONNECTOR and AUTOCUFF SYSTEM INSTRUMENT SET. Additional products include the OPUS MINIMAGNUM ANCHOR and various suture cartridges and cassettes for minimally invasive procedures.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where the manufacturer is based.
Catalogue
Search and filter all 13 devicesFrequently asked questions
How many devices does Opus Medical, Inc. have in the registry?
The registry currently lists 13 devices for Opus Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Opus Medical, Inc.'s devices?
Among its 13 most recently registered devices, Opus Medical, Inc. has devices listed in FDA 510(k) (13 devices).
What risk classes do Opus Medical, Inc.'s devices fall under?
Among its 13 most recently registered devices, the classes recorded for Opus Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Opus Medical, Inc. in the registry?
The most recently registered devices listed for Opus Medical, Inc. include OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE, OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500, F1 DIODE LASER SYSTEM and OPUS MAGNUM ANCHOR & INSERTER.