Identity
- Trade Name
- ANKLE COMPRESSION NAILING SYSTEM FDA UDI
- Generic Name
- Surgical torque wrench, reusable FDA UDI
- Device Name
- 24MM WRENCH FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- 24MM WRENCH FDA UDI
Identifiers
- Catalog Number
- 177072 FDA UDI
- Primary DI / UDI-DI
- 18033509859076 FDA UDI
- 510(k) Number
- K141571 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Surgical torque wrench, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Width — 52 Millimeter FDA UDI
Category: Surgical torque wrench, reusable
Ankle Compression Nailing System by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical torque wrench, reusable.
- XIA 3 — Stryker Corp. · Class I
- Momentum — ULRICH MEDICAL USA, INC. · Class II
- Mariner Deformity — SeaSpine Orthopedics Corporation · Class I
- Zavation — ZAVATION · Class II
- IMHS — Smith & Nephew, Inc. · Class II
- OXFORD ANKLE FUSION NAIL(AFN) SYSTEM — ORTHO SOLUTIONS HOLDINGS LIMITED · Class II
- X FIX — Biomet Orthopedics, Inc. · Class I
- BIONNOVATION — BIONNOVATION PRODUTOS BIOMEDICOS LTDA. · Class I
Cleared under the same submission
K141571 also covers:
- ANKLE COMPRESSION NAILING SYSTEM — Orthofix, Inc.
- ANKLE COMPRESSION NAILING SYSTEM — Orthofix, Inc.
- ANKLE COMPRESSION NAILING SYSTEM — Orthofix, Inc.
- ANKLE COMPRESSION NAILING SYSTEM — Orthofix, Inc.
- ANKLE COMPRESSION NAILING SYSTEM — Orthofix, Inc.
- ANKLE COMPRESSION NAILING SYSTEM — Orthofix, Inc.
- ANKLE COMPRESSION NAILING SYSTEM — Orthofix, Inc.
- ANKLE COMPRESSION NAILING SYSTEM — Orthofix, Inc.
- ANKLE COMPRESSION NAILING SYSTEM — Orthofix, Inc.
- ANKLE COMPRESSION NAILING SYSTEM — Orthofix, Inc.
- ANKLE COMPRESSION NAILING SYSTEM — Orthofix, Inc.
- ANKLE COMPRESSION NAILING SYSTEM — Orthofix, 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
- Orthofix, Inc.
Sources (1)
- FDA UDI 0821eb00-9d4e-4205-b2c5-8615bbf89218 37 fields · synced Jun 8, 2026