FDA Registration
Active
🇺🇸 United States
Orthopedic Manual Surgical Instrument
Reg #: 3010386387
·
FEI: 3010386387
·
Expires 2025
Products
1
Proprietary Names
23
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SINGLE SOURCE MEDICAL LLC
- Registration Number
- 3010386387
- FEI Number
- 3010386387
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4506 S State Road 9 57
- City
- Churubusco
- State
- IN
- ZIP
- 46723
- Country
- US
Owner / Operator
- Firm Name
- Single Source Medical LLC
- Operator Number
- 10043888
- Address
- 4506 IN 9-57
- City
- Churubusco
- State
- IN
- Postal Code
- 46723
- Country
- US
- Correspondent
- Tom Harris
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-04-03 |
Proprietary Names
Orthopedic Manual Surgical Instrument
SN 5181 K-K
Tibial resection Guide SN 5379
Extended Exact Broach Handle
Intramedullary Tribial Cut Guide Jig
Intramedullary Tibial Cut Guide Jig for the Persona TKA system SN 4852 AD-AD
82-0164-033-00 PATELLA TOOL
Left and Right Tibial cut Guide SN 4808 F-F
SN 4786 F-F
Intramedullary Tibial Cut Guide Jig for the Persona TKA system SN 4852 AB-AB
TIBIAL CUT GUIDE L & R SN 4808 F-F
SN 6325 A-A TRIGGER STYLE HIP STEM INSERTER
SN 6386 A-A REV C
SN 6069 D-D MODIFIED CUP INSERTER
DISSECTOR
SLAP HAMMER
SLAP HAMMER 2106-1002
DISSECTOR 7200-1041
INSERTER
SLAP HAMMER 7200-1065
7200-1034
SSI006764 Double Bundle Femoral Aimer 11 mm
SSI006765 Double Bundle Femoral Aimer 12mm
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)