Identity
- Trade Name
- Flower E-Kit, Advanced FDA UDI
- Generic Name
- Orthopaedic bone wire FDA UDI
- Device Name
- surgical instrument or accessory for orthopedic bone fixation FDA UDI
- Model / Reference
- EWK 201 FDA UDI
- Description
- surgical instrument or accessory for orthopedic bone fixation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840118112079 FDA UDI
- 510(k) Number
- K123562 FDA UDI
- FDA Product Code
- HTY FDA UDI
- GMDN Term
- Orthopaedic bone wire FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Category: Orthopaedic bone wire
Flower E-Kit, Advanced by Flower Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone wire.
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- SMOOTH K-WIRE, DOUBLE END TROCAR POINT — Biomet Orthopedics, Inc. · Class II
- mahe medical GmbH — mahe medical gmbh · Class II
- OIC Variable Angle Small Fragment Locking Plate System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
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- gSource — GSOURCE, LLC. · Class II
Cleared under the same submission
K123562 also covers:
- 1.0mm H&F H-Plate, 4x2 Holes, 1.5mm/2.0mm/2.4mm — FLOWER ORTHOPEDICS CORPORATION
- 1.0mm H&F L-Plate (L), 6 Holes, 1.5mm/2.0mm/2.4mm — FLOWER ORTHOPEDICS CORPORATION
- 1.0mm H&F L-Plate (R), 6 Holes, 1.5mm/2.0mm/2.4mm — FLOWER ORTHOPEDICS CORPORATION
- 1.0mm H&F Oblique T-Plate (R), 6 Holes, 1.5mm/2.0mm/2.4mm — FLOWER ORTHOPEDICS CORPORATION
- 1.0mm H&F Straight Plate, 6 Holes, 1.5mm/2.0mm/2.4mm — FLOWER ORTHOPEDICS CORPORATION
- 1.0mm H&F T-Plate, 6 Holes, 1.5mm/2.0mm/2.4mm — FLOWER ORTHOPEDICS CORPORATION
- 1.5mm H&F H-Plate, 3x2 Holes, 1.5mm/2.0mm/2.4mm — FLOWER ORTHOPEDICS CORPORATION
- 1.5mm H&F Oblique T-Plate (L), 6 Holes, 1.5mm/2.0mm/2.4mm — FLOWER ORTHOPEDICS CORPORATION
- 1.5mm H&F T-Plate, 7 Holes, 1.5mm/2.0mm/2.4mm — FLOWER ORTHOPEDICS CORPORATION
- 1.5mm Recon Plate, 5 Holes, 1.5mm/2.0mm/2.4mm — FLOWER ORTHOPEDICS CORPORATION
- 1.5mm Recon Plate, 7 Holes, 1.5mm/2.0mm/2.4mm — FLOWER ORTHOPEDICS CORPORATION
- 1.5mm Recon T-Plate, 4 Holes, 1.5mm/2.0mm/2.4mm — 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 c7716e47-d63c-44b7-a4fa-ef088a09e57c 34 fields · synced May 30, 2026