Identity
- Trade Name
- Locking Fibular Plate, 7 holes FDA UDI
- Generic Name
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile FDA UDI
- Device Name
- implants for orthopedic bone fixation compatible with 2.7mm/3.5mm/4.0mm Screws FDA UDI
- Model / Reference
- DLF 507 FDA UDI
- Description
- implants for orthopedic bone fixation compatible with 2.7mm/3.5mm/4.0mm Screws FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840118111928 FDA UDI
- 510(k) Number
- K133102 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Height — 1.7 Millimeter FDA UDI
Category: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Locking Fibular Plate, 7 holes by Flower Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile.
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- ACUMED — ACUMED LLC · Class II
- AlignMate — ARTHROSURFACE INCORPORATED · Class II
- ACUMED — ACUMED LLC · Class II
- NCB® — Zimmer, Inc. · Class II
- ACUMED — ACUMED LLC · Class II
- NCB® — Zimmer, Inc. · Class II
- NCB® — Zimmer, Inc. · Class II
Cleared under the same submission
K133102 also covers:
- Anatomic Distal Fibula Plate, 5 Holes, Left — FLOWER ORTHOPEDICS CORPORATION
- Anatomic Distal Fibula Plate, 5 Holes, Right — FLOWER ORTHOPEDICS CORPORATION
- Anatomic Distal Fibula Plate, 7 Holes, Left — FLOWER ORTHOPEDICS CORPORATION
- Anatomic Distal Fibula Plate, 7 Holes, Right — FLOWER ORTHOPEDICS CORPORATION
- Anatomic Distal Fibular Plate, 4 Holes, Left — FLOWER ORTHOPEDICS CORPORATION
- Anterior Lateral Distal Tibia Plate, 10 Holes — FLOWER ORTHOPEDICS CORPORATION
- Anterior Lateral Distal Tibia Plate, 10 Holes — FLOWER ORTHOPEDICS CORPORATION
- Anterior Lateral Distal Tibia Plate, 7 Holes — FLOWER ORTHOPEDICS CORPORATION
- Anterior Lateral Distal Tibia Plate, 7 Holes — FLOWER ORTHOPEDICS CORPORATION
- Distal Tibial A-Plate — FLOWER ORTHOPEDICS CORPORATION
- Locking Fibula Plate, 10 Holes — FLOWER ORTHOPEDICS CORPORATION
- Locking Fibula Plate, 5 Holes — FLOWER ORTHOPEDICS CORPORATION
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
- Flower Orthopedics Corporation
Sources (1)
- FDA UDI 3539744c-522a-4229-b939-feeb999a3036 35 fields · synced May 30, 2026