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osteo-WEDGE2 15 Degree Angulated Bone Plate Implant, Large
FDA UDIClass II (US FDA UDI)
by Gramedica
Identity
- Trade Name
- osteo-WEDGE2 15 Degree Angulated Bone Plate Implant, Large FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- 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-504-15 FDA UDI
- Description
- 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
- GM-504-15 FDA UDI
- Primary DI / UDI-DI
- M621GM504150 FDA UDI
- 510(k) Number
- K162179 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 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-WEDGE2 15 Degree Angulated Bone Plate Implant, Large 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
K162179 also covers:
- osteo-WEDGE2 0 Degree, Flat Bone Plate Implant, Small — Gramedica
- osteo-WEDGE2 12 Degree Angulated Bone Plate Implant, Large — Gramedica
- osteo-WEDGE2 12 Degree Angulated Bone Plate Implant, Small — Gramedica
- osteo-WEDGE2 15 Degree Angulated Bone Plate Implant, Small — Gramedica
- osteo-WEDGE2 18 Degree Angulated Bone Plate Implant, Large — Gramedica
- osteo-WEDGE2 18 Degree Angulated Bone Plate Implant-Small — Gramedica
- osteo-WEDGE2 21 Degree Angulated Bone Plate Implant, Large — Gramedica
- osteo-WEDGE2 21 Degree Angulated Bone Plate Implant, Small — Gramedica
- osteo-WEDGE2 24 Degree Angulated Bone Plate Implant, Large — Gramedica
- osteo-WEDGE2 24 Degree Angulated Bone Plate Implant, Small — Gramedica
- osteo-WEDGE2 27 Degree Angulated Bone Plate Implant, Large — Gramedica
- osteo-WEDGE2 27 Degree Angulated Bone Plate Implant, Small — 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 |
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Manufacturer
- Manufacturer
- Gramedica
Sources (1)
- FDA UDI 11f3ec0b-84e9-42d8-b203-e7dce9a5482e 35 fields · synced May 30, 2026