Identity
- Trade Name
- Hayden Medical FDA UDI
- Generic Name
- Bone approximation clamp FDA UDI
- Device Name
- Sesamoidectomy Clamp, slightly curved, 6 1/2"( 16.5 cm) FDA UDI
- Model / Reference
- 140-557 FDA UDI
- Description
- Sesamoidectomy Clamp, slightly curved, 6 1/2"( 16.5 cm) FDA UDI
Identifiers
- Catalog Number
- 140-557 FDA UDI
- Primary DI / UDI-DI
- 00840319740767 FDA UDI
- FDA Product Code
- HDX FDA UDI
- GMDN Term
- Bone approximation clamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.3900 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
Yes
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
A hand-held manual surgical instrument designed to grip and hold a bone or, being used in pairs one on either side of the fracture, to approximate the proximal and distal segment of a fractured bone during orthopaedic surgery.
Similar devices
Also classified as Bone approximation clamp.
- Journey II — Smith & Nephew, Inc. · Class II
- PERI-LOC VLP — Smith & Nephew, Inc. · Class II
- LEGION — Smith & Nephew, Inc. · Class I
- Bone Clamp — Koros USA, Inc. · Class I
- PROFIX — Smith & Nephew, Inc. · Class II
- Sklar® — Sklar Corporation · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Symmetry Martin — SYMMETRY SURGICAL INC. · Class I
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
- Hayden Medical Inc
Sources (1)
- FDA UDI e6efb729-753b-4221-94d7-88a846273540 35 fields · synced Jun 22, 2026