Identity
- Trade Name
- Journey II FDA UDI
- Generic Name
- Bone approximation clamp FDA UDI
- Device Name
- ANKLE CLAMP FDA UDI
- Model / Reference
- E0016425-2 FDA UDI
- Description
- ANKLE CLAMP FDA UDI
Identifiers
- Catalog Number
- E0016425-2 FDA UDI
- Primary DI / UDI-DI
- 00885556742112 FDA UDI
- 510(k) Number
- K121393 FDA UDI
- FDA Product Code
- HRY FDA UDI
- GMDN Term
- Bone approximation clamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3530 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: Bone approximation clamp
Journey II by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone approximation clamp.
- Bone Clamp — Koros USA, Inc. · Class I
- Sklar® — Sklar Corporation · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Symmetry Martin — SYMMETRY SURGICAL INC. · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Sklar® — Sklar Corporation · Class I
- SAMPEDRO — Industrias Medicas Sampedro S.A.S · Class I
- FEMORAL BONE CLAMP — Biomet Orthopedics, Inc. · Class I
Cleared under the same submission
K121393 also covers:
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GII — Smith & Nephew, Inc.
- Genesis II — Smith & Nephew, Inc.
- Genesis II — Smith & Nephew, Inc.
- Genesis II — Smith & Nephew, Inc.
- IMHS — Smith & Nephew, Inc.
- JOURNEY — 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 |
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Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 111d80aa-c12c-45ad-9512-1d3ab11ea1fe 36 fields · synced Jun 8, 2026