Identity
- Trade Name
- Curved Lasso Guide FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Curved Lasso Guide FDA UDI
- Model / Reference
- T100871 FDA UDI
- Description
- Curved Lasso Guide FDA UDI
Identifiers
- Primary DI / UDI-DI
- G523T1008710 FDA UDI
- 510(k) Number
- K232780 FDA UDI
- FDA Product Code
- HTN FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 146.5 Millimeter FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
Curved Lasso Guide by Cc-Instruments Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K232780 also covers:
- Clavicle Clip - 16mm — Cc-Instruments Inc.
- Clavicle Clip - 20mm — Cc-Instruments Inc.
- Straight Lasso Guide — Cc-Instruments Inc.
- Sub-Coracoid Clip - Round 10mm — Cc-Instruments Inc.
- Sub-Coracoid Clip - Round 10mm, Curved — Cc-Instruments Inc.
- Sub-Coracoid Clip - Round 12mm — Cc-Instruments Inc.
- Sub-Coracoid Clip - Round 12mm, Curved — Cc-Instruments Inc.
- Sub-Coracoid Clip - Small, Rectangle — Cc-Instruments Inc.
- Sub-Coracoid Clip - Small, Rectangle, Curved — Cc-Instruments Inc.
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 |
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Manufacturer
- Manufacturer
- Cc-Instruments Inc.
Sources (1)
- FDA UDI b5bfe1e6-b6ba-449b-9632-25e558b62add 35 fields · synced May 29, 2026