Identity
- Trade Name
- Locking Proximal Femur FDA UDI
- Generic Name
- Growth-correction orthopaedic fixation plate kit FDA UDI
- Device Name
- 3.5mm 90° DFOS Plate, 5° Flare, No Offset, 8 Hole FDA UDI
- Model / Reference
- 00-1050-5008 FDA UDI
- Description
- 3.5mm 90° DFOS Plate, 5° Flare, No Offset, 8 Hole FDA UDI
Identifiers
- Catalog Number
- 00-1050-5008 FDA UDI
- Primary DI / UDI-DI
- 00841132129838 FDA UDI
- 510(k) Number
- K111086 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 Proximal Femur by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Growth-correction orthopaedic fixation plate kit.
- PROVIEW — Orthofix US LLC · Class I
- PROVIEW — Orthofix US LLC · Class I
- NAVIGATED INSTRUMENTS;PHOENIX SFS — Orthofix US LLC · Class II
- PROVIEW — Orthofix US LLC · Class I
- PROVIEW — Orthofix US LLC · Class I
- PROVIEW — Orthofix US LLC · Class I
- PROVIEW — Orthofix US LLC · Class I
- NAVIGATED INSTRUMENTS;FIREBIRD NXG — Orthofix US LLC · Class II
Cleared under the same submission
K111086 also covers:
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — ORTHOPEDIATRICS CORP.
- Locking Proximal Femur — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthopediatrics Corp.
Sources (1)
- FDA UDI d2b5d578-275b-4d7a-ba9d-253481e9efb9 36 fields · synced May 31, 2026