Identity
- Trade Name
- Locking Cannulated Blade Plate System FDA UDI
- Generic Name
- Growth-correction orthopaedic fixation plate kit FDA UDI
- Device Name
- 100 deg Cannulated Child Blade Plate 50mm X 10mm Offset X 3 Hole FDA UDI
- Model / Reference
- 00-1200-4011 FDA UDI
- Description
- 100 deg Cannulated Child Blade Plate 50mm X 10mm Offset X 3 Hole FDA UDI
Identifiers
- Catalog Number
- 00-1200-4011 FDA UDI
- Primary DI / UDI-DI
- 00841132110133 FDA UDI
- 510(k) Number
- K110959 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Growth-correction orthopaedic fixation plate kit 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
No
FDA UDI
Category: Growth-correction orthopaedic fixation plate kit
Locking Cannulated Blade Plate System by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Growth-correction orthopaedic fixation plate kit.
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- PROVIEW — Orthofix US LLC · Class I
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Cleared under the same submission
K110959 also covers:
- Locking Cannulated Blade Plate — ORTHOPEDIATRICS CORP.
- Locking Cannulated Blade Plate — ORTHOPEDIATRICS CORP.
- Locking Cannulated Blade Plate — ORTHOPEDIATRICS CORP.
- Locking Cannulated Blade Plate — ORTHOPEDIATRICS CORP.
- Locking Cannulated Blade Plate — ORTHOPEDIATRICS CORP.
- Locking Cannulated Blade Plate — ORTHOPEDIATRICS CORP.
- Locking Cannulated Blade Plate — ORTHOPEDIATRICS CORP.
- Locking Cannulated Blade Plate — ORTHOPEDIATRICS CORP.
- Locking Cannulated Blade Plate — ORTHOPEDIATRICS CORP.
- Locking Cannulated Blade Plate — ORTHOPEDIATRICS CORP.
- Locking Cannulated Blade Plate — ORTHOPEDIATRICS CORP.
- Locking Cannulated Blade Plate System — ORTHOPEDIATRICS CORP.
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
- Orthopediatrics Corp.
Sources (1)
- FDA UDI d843e7cf-2daa-4ad5-9622-c3a19b4d7c07 36 fields · synced Jun 6, 2026