FDA Registration
Active
🇺🇸 United States
Versalok Pre-packed W/Orthocord
Reg #: 1221934
·
FEI: 1221934
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- DePuy Mitek, Inc.
- Registration Number
- 1221934
- FEI Number
- 1221934
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 325 Paramount Dr
- City
- RAYNHAM
- State
- MA
- ZIP
- 02767
- Country
- US
Regulatory Submissions
- 510(k) Number
- K063478
Owner / Operator
- Firm Name
- DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
- Operator Number
- 1221934
- Address
- 4600 Riverside Drive, --
- City
- Palm Beach Gardens
- State
- FL
- Postal Code
- 33410
- Country
- US
- Correspondent
- Karen Parker
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2012-01-17 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2012-01-17 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2012-01-17 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2012-01-17 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2012-01-17 |
| Suture, Nonabsorbable, Synthetic, Polyester | GAS | Class 2 | General, Plastic Surgery | No | 2012-01-17 |
Proprietary Names
Versalok Pre-packed W/Orthocord
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility