FDA Registration
Active
🇺🇸 United States
SYNTHES STERILE DRILL BITS
Reg #: 3004464325
·
FEI: 3004464325
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- DEPUY ORTHOPAEDICS
- Registration Number
- 3004464325
- FEI Number
- 3004464325
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 50 SCOTLAND BLVD.
- City
- BRIDGEWATER
- State
- MA
- ZIP
- 02324
- Country
- US
Regulatory Submissions
- 510(k) Number
- K962913
Owner / Operator
- Firm Name
- DePuy Synthes, Inc.
- Operator Number
- 1818910
- Address
- 700 Orthopaedic Drive
- City
- Warsaw
- State
- IN
- Postal Code
- 46582
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2023-08-17 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2023-08-17 |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | Class 1 | General, Plastic Surgery | No | 2023-08-17 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2023-08-17 |
Proprietary Names
SYNTHES STERILE DRILL BITS
Establishment Types
Repack or Relabel Medical Device