HyperFlex® Bunion Correction System

Primary DI
G559FB2910LFT0
Brand
HyperFlex® Bunion Correction System
Company
HYPERFLEX MEDICAL INC.
Model
FB-2910-LFT
Device description
Pack:Sizer/K-wire Pack Left
Published
2025-06-12
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
K241995000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241995000HyperFlex™ Bunion Correction SystemFootbridge Medical2024-11-26HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G559FB2910LFT0PrimaryHIBCC0

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
Kit
true
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
G559HF2910LFT0HyperFlex® Bunion Correction SystemHF-2910-LFT2026-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904255300064ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300071ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300088ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300095ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300101ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300118ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300125ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300132ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300149ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300156ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300163ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300170ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300187ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300194ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300200ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300217ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300224ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300231ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300248ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300255ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300262ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300705ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300712ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300729ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300736ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300743ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300750ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300767ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300774ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300781ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18