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osteo-WEDGE 2.5mm x 20mm Locking Bone Screw
FDA UDIClass II (US FDA UDI)
by Gramedica
Identity
- Trade Name
- osteo-WEDGE 2.5mm x 20mm Locking Bone Screw FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- osteo-WEDGE 2.5mm x 20mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. FDA UDI
- Model / Reference
- GM-200-20 FDA UDI
- Description
- osteo-WEDGE 2.5mm x 20mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. FDA UDI
Identifiers
- Catalog Number
- OW2.5LBS-20MM FDA UDI
- Primary DI / UDI-DI
- M621OW25LBS20MM0 FDA UDI
- 510(k) Number
- K111326 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic fixation plate, 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
osteo-WEDGE 2.5mm x 20mm Locking Bone Screw by Gramedica — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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Cleared under the same submission
K111326 also covers:
- osteo-WEDGE 2.5mm x 08mm Locking Bone Screw — Gramedica
- osteo-WEDGE 2.5mm x 10mm Locking Bone Screw — Gramedica
- osteo-WEDGE 2.5mm x 12mm Locking Bone Screw — Gramedica
- osteo-WEDGE 2.5mm x 14mm Locking Bone Screw — Gramedica
- osteo-WEDGE 2.5mm x 16mm Locking Bone Screw — Gramedica
- osteo-WEDGE 2.5mm x 18mm Locking Bone Screw — Gramedica
- osteo-WEDGE 2.5mm x 22mm Locking Bone Screw — Gramedica
- osteo-WEDGE 3.0mm x 08mm Locking Bone Screw — Gramedica
- osteo-WEDGE 3.0mm x 10mm Locking Bone Screw — Gramedica
- osteo-WEDGE 3.0mm x 12mm Locking Bone Screw — Gramedica
- osteo-WEDGE 3.0mm x 14mm Locking Bone Screw — Gramedica
- osteo-WEDGE 3.0mm x 16mm Locking Bone Screw — Gramedica
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
- Gramedica
Sources (1)
- FDA UDI d87496a2-5ff2-4e00-a640-9c6d74f11d93 37 fields · synced Jun 8, 2026