FDA Registration
Active
🇦🇺 Australia
Imboki Instrument Set
Reg #: 3008262872
·
FEI: 3008262872
·
Expires 2025
Products
1
Proprietary Names
36
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SIGNATURE ORTHOPAEDICS PTY LIMITED
- Registration Number
- 3008262872
- FEI Number
- 3008262872
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7 Sirius Road, Lane Cove West
- City
- Sydney New South Wales
- Country
- AU
Owner / Operator
- Firm Name
- Signature Orthopaedics Pty Limited
- Operator Number
- 10037793
- Address
- 7 Sirius Road
- City
- Lane Cove West
- State
- New South Wales
- Postal Code
- 2066
- Country
- AU
- Correspondent
- Declan P Brazil
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2011-08-16 |
Proprietary Names
Imboki Instrument Set
Tibial Alignment Guide
TSI Starter Rasp
Femoral Broach
Uni Polar Head Inserter
Slap Hammer
X8 Locking Driver
Liner Collar Popper
Ratchet Driver
Total Hip Instrument
Liner Impactor
Bipolar Head Fitting Jig
Bipolar Head Inserter
Cup Inserter
Multi Axial Hex Driver
Clutch Screw Driver
Ball Joint Driver
Lightning Curved Reamer Handle
Calcar Reamer
Monobloc Hex Driver
Screw Forceps
Liner Inserter
Head Extractor
Stem Extractor
Acetabular Reamer
The Happy Gilmore
Head Impactor
Reamer Handle
Femoral Head Extractor
Flexible Driver
T-Handle
Femoral Sound
Screw Inserter
Tapered Hex Driver
Bipolar Scissors
Trial Inserter
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device