HyperFlex® Bunion Correction System

Primary DI
G559HF2331RT0
Brand
HyperFlex® Bunion Correction System
Company
HYPERFLEX MEDICAL INC.
Model
HF-2331-RT
Device description
Hyperflex Large-Large-Right - Titanium
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
G559HF2331RT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
G559HF29000HyperFlex® Bunion Correction SystemHF-29002026-01-01
G559HF2910LFT0HyperFlex® Bunion Correction SystemHF-2910-LFT2026-01-01
G559HF2910RT0HyperFlex® Bunion Correction SystemHF-2910-RT2026-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630894822858APTUSMedartis AGHRS2026-07-16
07630894822865APTUSMedartis AGHRS2026-07-16
07630894822872APTUSMedartis AGHRS2026-07-16
07630894822889APTUSMedartis AGHRS2026-07-16
07630894822896APTUSMedartis AGHRS2026-07-16
07630894822902APTUSMedartis AGHRS2026-07-16
07630894822919APTUSMedartis AGHRS2026-07-16
07630894822926APTUSMedartis AGHRS2026-07-16
07630894822933APTUSMedartis AGHRS2026-07-16
07630894822940APTUSMedartis AGHRS2026-07-16
07630894822957APTUSMedartis AGHRS2026-07-16
07630894822964APTUSMedartis AGHRS2026-07-16
07630894822971APTUSMedartis AGHRS2026-07-16
07630894822988APTUSMedartis AGHRS2026-07-16
07630894822995APTUSMedartis AGHRS2026-07-16
07630894823008APTUSMedartis AGHRS2026-07-16
07630894823015APTUSMedartis AGHRS2026-07-16
07630894823022APTUSMedartis AGHRS2026-07-16
07630894823039APTUSMedartis AGHRS2026-07-16
07630894823053APTUSMedartis AGHRS2026-07-16
07630894823060APTUSMedartis AGHRS2026-07-16
07630894823084APTUSMedartis AGHRS2026-07-16
07630894823091APTUSMedartis AGHRS2026-07-16
07630894823114APTUSMedartis AGHRS2026-07-16
07630894823121APTUSMedartis AGHRS2026-07-16
07630894823145APTUSMedartis AGHRS2026-07-16
07630894823152APTUSMedartis AGHRS2026-07-16
07630894823176APTUSMedartis AGHRS2026-07-16
07630894823183APTUSMedartis AGHRS2026-07-16
07630894823206APTUSMedartis AGHRS2026-07-16