FDA.reportPublic FDA data

HyperFlex® Reduction Clamp

Primary DI
G559FB1030000
Brand
HyperFlex® Reduction Clamp
Company
HYPERFLEX MEDICAL INC.
Model
FB-1030-00
Device description
FootBridge Reduction Clamp
Published
2025-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G559FB1030000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
119512231
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
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
00841523183081Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523183746Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185030Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185047Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185054Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185061Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185078Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185092Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185108Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185139Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185146Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185153Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185160Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185177Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185382Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
B382SD484620Surgical DirectSurgical Direct, Inc.LXH2026-08-07
M7409200004MIS TLIF SystemSPINEOLOGY INC.LXH2026-08-07
00199150083473Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-08-03
B382SD480033220Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD480090Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
00190776407391MillenniumAvalign Technologies, Inc.LXH2026-07-31
00840606191579Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191630Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191647Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191678Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191685Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191692Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191708Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31