Identity
- Trade Name
- TC-100 FDA UDI
- Generic Name
- Manual goniometer FDA UDI
- Device Name
- 100 60 20 DEGREE TRIANGULAR POSITIONING PLATE SM FDA UDI
- Model / Reference
- 71175420 FDA UDI
- Description
- 100 60 20 DEGREE TRIANGULAR POSITIONING PLATE SM FDA UDI
Identifiers
- Catalog Number
- 71175420 FDA UDI
- Primary DI / UDI-DI
- 00885556016657 FDA UDI
- 510(k) Number
- K123055 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Manual goniometer 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
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: Manual goniometer
Tc-100 by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K123055 also covers:
- BIRMINGHAM HIP RESURFACING(BHR) — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- Cannulated Screws — Smith & Nephew, Inc.
- Cannulated Screws — Smith & Nephew, Inc.
- Cannulated Screws — Smith & Nephew, Inc.
- Jet-X — Smith & Nephew, Inc.
- LARGE CANNULATED SCREWS — Smith & Nephew, Inc.
- LARGE CANNULATED SCREWS — Smith & Nephew, Inc.
- LARGE CANNULATED SCREWS — Smith & Nephew, Inc.
- LEGION — Smith & Nephew, Inc.
- LEGION — Smith & Nephew, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI b9bc1557-2b8d-4563-a370-c9b9fccdbc72 36 fields · synced Jun 8, 2026