FDA.reportPublic FDA data

HyperFlex® Bunion Correction System

Primary DI
G559HF2910LFT0
Brand
HyperFlex® Bunion Correction System
Company
HYPERFLEX MEDICAL INC.
Model
HF-2910-LFT
Device description
Sizer / K-wire Pack - Left
Published
2026-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252997000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252997000HyperFlex® Bunion Correction SystemHyperflex Medical2025-12-11HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G559HF2910LFT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, single-useA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119512231
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G559HF2111LFT0HyperFlex® Bunion Correction SystemHF-2111-LFT2026-01-01
G559HF2111RT0HyperFlex® Bunion Correction SystemHF-2111-RT2026-01-01
G559HF2121LFT0HyperFlex® Bunion Correction SystemHF-2121-LFT2026-01-01
G559HF2121RT0HyperFlex® Bunion Correction SystemHF-2121-RT2026-01-01
G559HF2131LFT0HyperFlex® Bunion Correction SystemHF-2131-LFT2026-01-01
G559HF2131RT0HyperFlex® Bunion Correction SystemHF-2131-RT2026-01-01
G559HF2211LFT0HyperFlex® Bunion Correction SystemHF-2211-LFT2026-01-01
G559HF2211RT0HyperFlex® Bunion Correction SystemHF-2211-RT2026-01-01
G559HF2221LFT0HyperFlex® Bunion Correction SystemHF-2221-LFT2026-01-01
G559HF2221RT0HyperFlex® Bunion Correction SystemHF-2221-RT2026-01-01
G559HF2231LFT0HyperFlex® Bunion Correction SystemHF-2231-LFT2026-01-01
G559HF2231RT0HyperFlex® Bunion Correction SystemHF-2231-RT2026-01-01
G559HF2311LFT0HyperFlex® Bunion Correction SystemHF-2311-LFT2026-01-01
G559HF2311RT0HyperFlex® Bunion Correction SystemHF-2311-RT2026-01-01
G559HF2321LFT0HyperFlex® Bunion Correction SystemHF-2321-LFT2026-01-01
G559HF2321RT0HyperFlex® Bunion Correction SystemHF-2321-RT2026-01-01
G559HF2331LFT0HyperFlex® Bunion Correction SystemHF-2331-LFT2026-01-01
G559HF2331RT0HyperFlex® Bunion Correction SystemHF-2331-RT2026-01-01
G559HF29000HyperFlex® Bunion Correction SystemHF-29002026-01-01
G559HF2910RT0HyperFlex® Bunion Correction SystemHF-2910-RT2026-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889095401820ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401844ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401868ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401882ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401905ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401929ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402285ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402438ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402483ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402537ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411263ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411287ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411300ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411324ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095611274ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
10886982350732VOLTSynthes GmbHHRS2026-09-25
10886982350749VOLTSynthes GmbHHRS2026-09-25
10886982350756VOLTSynthes GmbHHRS2026-09-25
10886982350763VOLTSynthes GmbHHRS2026-09-25
10886982350770VOLTSynthes GmbHHRS2026-09-25
10886982350787VOLTSynthes GmbHHRS2026-09-25
10886982350794VOLTSynthes GmbHHRS2026-09-25
10886982350800VOLTSynthes GmbHHRS2026-09-25
10886982350817VOLTSynthes GmbHHRS2026-09-25
10886982350824VOLTSynthes GmbHHRS2026-09-25
10886982350831VOLTSynthes GmbHHRS2026-09-25
10886982350848VOLTSynthes GmbHHRS2026-09-25
10886982350855VOLTSynthes GmbHHRS2026-09-25
10886982350862VOLTSynthes GmbHHRS2026-09-25
10886982350879VOLTSynthes GmbHHRS2026-09-25