Identity
- Trade Name
- HyperFlex® Bunion Correction System FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, single-use FDA UDI
- Device Name
- Pack:Sizer/K-wire Pack Right FDA UDI
- Model / Reference
- FB-2910-RT FDA UDI
- Description
- Pack:Sizer/K-wire Pack Right FDA UDI
Identifiers
- Primary DI / UDI-DI
- G559FB2910RT0 FDA UDI
- 510(k) Number
- K241995 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Surgical implant/trial-implant/sizer holder, single-use 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
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: Surgical implant/trial-implant/sizer holder, single-use
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 Surgical implant/trial-implant/sizer holder, single-use.
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- Nextra Hammertoe Correction System — Medartis Inc. · Class I
- restor3d Disposable Instrument, Cervical Cage Trial — Restor3D · Class I
- DynaBridge — FUSION ORTHOPEDICS, LLC · Class II
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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 a7f3a3aa-6625-4886-b35a-e3369217bacc 34 fields · synced May 30, 2026