Identity
- Trade Name
- Opti-Toe-Small Angle FDA UDI
- Generic Name
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
- Device Name
- The Opti-Toe-Small Angle Implant is comprised of two mated components (proximal and middle phalangeal) which join together to form a single intramedullary fixation unit. Indications: The GraMedica opti-Toe Device is indicate for reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The GraMedica opti-Toe components are to be cemented in place and assembled for reconstruction of the toe. Patients should protect weight-bearing or heal bearing until healing has occurred. FDA UDI
- Model / Reference
- OT-SA FDA UDI
- Description
- The Opti-Toe-Small Angle Implant is comprised of two mated components (proximal and middle phalangeal) which join together to form a single intramedullary fixation unit. Indications: The GraMedica opti-Toe Device is indicate for reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The GraMedica opti-Toe components are to be cemented in place and assembled for reconstruction of the toe. Patients should protect weight-bearing or heal bearing until healing has occurred. FDA UDI
Identifiers
- Catalog Number
- OT-SA FDA UDI
- Primary DI / UDI-DI
- M621OTSA0 FDA UDI
- 510(k) Number
- K142478 FDA UDI
- FDA Product Code
- HTY FDA UDI
- GMDN Term
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic bone pin, non-bioabsorbable
Opti-Toe-Small Angle by Gramedica — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone pin, non-bioabsorbable.
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Cleared under the same submission
K142478 also covers:
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
- Gramedica
Sources (1)
- FDA UDI 2f0932b5-7a19-4bd6-b529-1b5e99ab70af 35 fields · synced Jun 8, 2026