FDA Registration
Active
🇺🇸 United States
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Reg #: 3034676720
·
FEI: 3034676720
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- DePuy Synthes Sales
- Registration Number
- 3034676720
- FEI Number
- 3034676720
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 75 Fruit St
- City
- Bridgewater
- State
- MA
- ZIP
- 02324
- Country
- US
Regulatory Submissions
- 510(k) Number
- K183113
Owner / Operator
- Firm Name
- SYNTHES (USA) Products LLC / Medical Device Business Service
- Operator Number
- 2520274
- Address
- 1301 Goshen Parkway, --
- City
- West Chester
- State
- PA
- Postal Code
- 19380
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Fixation, Intraosseous | DZK | Class 2 | Dental | No | 2020-02-26 |
| Prosthesis, Condyle, Mandibular, Temporary | NEI | Class 2 | Dental | No | 2020-02-26 |
| Implant, Endosseous, Orthodontic | OAT | Class 2 | Dental | No | 2020-02-26 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2020-02-26 |
| External Mandibular Fixator And/Or Distractor | MQN | Class 2 | Dental | No | 2020-02-26 |
Proprietary Names
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Establishment Types
Repack or Relabel Medical Device