Identity
- Trade Name
- Femoral Cut Block, Central Capture, Klassic ONE FDA UDI
- Generic Name
- Orthopaedic implant aiming/guiding block, reusable FDA UDI
- Device Name
- Femoral Cut Block, Central Capture, Size 1 FDA UDI
- Model / Reference
- 2141.01.000 FDA UDI
- Description
- Femoral Cut Block, Central Capture, Size 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00819251029605 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic implant aiming/guiding block, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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: Orthopaedic implant aiming/guiding block, reusable
Femoral Cut Block, Central Capture, Klassic ONE by Total Joint Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant aiming/guiding block, reusable.
- TriVerse Tibial Offset Cutting Block — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
- MAXIM STEMMED TIBIAL MASK — Biomet Orthopedics, Inc. · Class I
- VISIONAIRE — Smith & Nephew, Inc. · Class II
- INBONE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
- Oxford Uni Knee System — Biomet Uk Ltd · Class I
- OIC Variable Angle Small Fragment Locking Plate System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- Journey — Smith & Nephew, Inc. · Class I
- Unity Total Knee System — CORIN LTD · Class II
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Total Joint Orthopedics, Inc.
Sources (1)
- FDA UDI 3d359079-7597-42ec-a4d8-af6f898c7410 36 fields · synced May 30, 2026