FDA Registration
Active
🇺🇸 United States
BioBrace Reinforced BioInductive Implant
Reg #: 3019101334
·
FEI: 3019101334
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ConMed Corporation
- Registration Number
- 3019101334
- FEI Number
- 3019101334
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 470 James St Ste 003
- City
- New Haven
- State
- CT
- ZIP
- 06513
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242187
Owner / Operator
- Firm Name
- CONMED CORPORATION
- Operator Number
- 1317214
- Address
- 11311 Concept Boulevard, --
- City
- Largo
- State
- FL
- Postal Code
- 33773
- Country
- US
- Correspondent
- Brent Lalomia
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament | QWJ | Class 2 | General, Plastic Surgery | No | 2025-04-08 |
| Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon | OWW | Class 2 | General, Plastic Surgery | No | 2025-04-08 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2025-04-08 |
| Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | OWY | Class 2 | General, Plastic Surgery | No | 2025-04-08 |
Proprietary Names
BioBrace Reinforced BioInductive Implant
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility