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Bending Template, Perimeter Calcaneal Plate, Extra Small
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- BENDING TEMPLATE,PERIMETER CALCANEAL PLATE,EXTRA SMALL FDA UDI
- Generic Name
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI
- Model / Reference
- 0548-010 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665037463 FDA UDI
- 510(k) Number
- K182466 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Bending Template, Perimeter Calcaneal Plate, Extra Small by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile.
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- ANTHEM — GLOBUS MEDICAL, INC. · Class II
- ANTHEM — GLOBUS MEDICAL, INC. · Class II
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- ACUMED — ACUMED LLC · Class II
Cleared under the same submission
K182466 also covers:
- 4.0mm Half Pin — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- 5.0mm Half Pin — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- BENDING TEMPLATE, MINIMALLY INVASIVE CALCANEAL PLATE, EXTRA SMALL — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Bending Template, Minimally Invasive Calcaneus Plate, Large — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Bending Template, Minimally Invasive Calcaneus Plate, Medium — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Bending Template, Minimally Invasive Calcaneus Plate, Small — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Bending Template, Perimeter Plate, Large — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Bending Template, Perimeter Plate, Medium — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Bending Template, Perimeter Plate, Small — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- CALCANEAL DROP-IN TRAY — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- FIBONACCI CALCANEAL PLATE TRAY — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- MINIMALLY INVASIVE CALCANEAL PLATE, LEFT, EXTRA SMALL — ADVANCED ORTHOPAEDIC SOLUTIONS, 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
- Advanced Orthopaedic Solutions, Inc.
Sources (1)
- FDA UDI 30905950-4b7a-4a9e-8cfc-b257899259fc 34 fields · synced May 31, 2026