Identity
- Trade Name
- HyperFlex® Bunion Correction System FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- "Pack:Implant:Stainless Steel:1st Met plate - Sterile Pack- Large - Left" FDA UDI
- Model / Reference
- FB-2300-LFT FDA UDI
- Description
- "Pack:Implant:Stainless Steel:1st Met plate - Sterile Pack- Large - Left" FDA UDI
Identifiers
- Primary DI / UDI-DI
- G559FB2300LFT0 FDA UDI
- 510(k) Number
- K241995 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
HyperFlex® Bunion Correction System by HyperFlex Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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Cleared under the same submission
K241995 also covers:
- HyperFlex® Bunion Correction System — HyperFlex Medical Inc
- HyperFlex® Bunion Correction System — HyperFlex Medical Inc
- HyperFlex® Bunion Correction System — HyperFlex Medical Inc
- HyperFlex® Bunion Correction System — HyperFlex Medical Inc
- HyperFlex® Bunion Correction System — HyperFlex Medical Inc
- HyperFlex® Bunion Correction System — HyperFlex Medical Inc
- HyperFlex® Bunion Correction System — HyperFlex Medical Inc
- HyperFlex® Bunion Correction System — HyperFlex Medical Inc
- HyperFlex® Bunion Correction System — HyperFlex Medical Inc
- HyperFlex® Bunion Correction System — HyperFlex Medical Inc
- HyperFlex® Bunion Correction System — HyperFlex Medical Inc
- HyperFlex® Bunion Correction System — HyperFlex Medical 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
- HyperFlex Medical Inc
Sources (1)
- FDA UDI f13b0862-8056-41a6-ac68-91df5e9df796 35 fields · synced May 30, 2026