Identity
- Trade Name
- Double offset Broach handle FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- Double offset Broach handle LEFT M2 Connection FDA UDI
- Model / Reference
- Broach Handle FDA UDI
- Description
- Double offset Broach handle LEFT M2 Connection FDA UDI
Identifiers
- Catalog Number
- 9095.11.008 FDA UDI
- Primary DI / UDI-DI
- 08033390103787 FDA UDI
- 510(k) Number
- K140975 FDA UDI
- FDA Product Code
- LZO FDA UDIJDI FDA UDIKWY FDA UDIKWZ FDA UDILPH FDA UDI
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3350 FDA UDI888.3390 FDA UDI888.3310 FDA UDI888.3358 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument handle, non-torque-limiting
Double offset Broach handle by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical instrument handle, non-torque-limiting.
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Cleared under the same submission
K140975 also covers:
- C2 REVISION Hip — Limacorporate
- Canal Chisel — Limacorporate
- MASTER SL Stem — Limacorporate
- MASTER SL Stem — Limacorporate
- MASTER SL Stem — Limacorporate
- MASTER SL Stem — Limacorporate
- MASTER SL Stem — Limacorporate
- MASTER SL Stem — Limacorporate
- MASTER SL Stem — Limacorporate
- MASTER SL Stem — Limacorporate
- MASTER SL Stem — Limacorporate
- MASTER SL Stem — Limacorporate
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Limacorporate
Sources (1)
- FDA UDI 5059f16f-dd35-4c46-a74e-d99cdb37f02a 36 fields · synced May 30, 2026