Data / Medical devices / United States / ConMed Corporation
ConMed Corporation: FDA-registered device maker in New Haven, CT, United States, 3 510(k) clearances
ConMed Corporation is registered with the FDA (registration 3019101334) in New Haven, CT, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 27, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019101334
- Address
- 470 James St Ste 003, New Haven, CT, United States, 06513
- Owner or operator
- CONMED CORPORATION (1317214)
- Roles
- Specification developer
- First device listed
- June 20, 2024
- Registered through
- 2026
- Brand names listed
- BioBrace Reinforced BioInductive Implant, BioBrace Reinforced Implant, BioBrace® Reinforced Implant
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon | OWW | 2 | Specification developer | accessdata.fda.gov |
| Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | OWY | 2 | Specification developer | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | Specification developer | accessdata.fda.gov |
| Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament | QWJ | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 27, 2024 | K242187 | BioBrace® | OWW | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 29, 2024 | K241906 | BioBrace® Reinforced Implant | OWW | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| April 30, 2021 | K203267 | The BioBrace Implant | OWW | Substantially Equivalent | Biorez, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- All makers of Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
- All makers of Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament
- All makers of Mesh, Surgical, Polymeric
Updated November 27, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.