FDA.report

PediFlex Advanced ILC

Primary DI
00840194428026
Brand
PediFlex Advanced ILC
Company
ORTHOPEDIATRICS CORP.
Model
01-1001-1006
Catalog number
01-1001-1006
Device description
Flex Nail T-Handle Inserter Wrench
Published
2023-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HXCWRENCH

Product Code Classifications

CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840194428026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194428026008401944280268401944280260840194428026

GMDN Terms

TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
796416191
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840194498975Response 5.5/6.001-1300-935001-1300-93502026-03-03
00840194498982Response 5.5/6.001-1300-936001-1300-93602026-03-03
00840536800244Response 5.5/6.001-1300-913501-1300-91352026-03-03
00840536800251Response 5.5/6.001-1300-913601-1300-91362026-03-03
00840194499194Contracture ManagementNS-6000-3001NS-6000-30012026-03-02
00840194499200Contracture ManagementNS-6000-3002NS-6000-30022026-03-02
00840194499217Contracture ManagementNS-6000-3003NS-6000-30032026-03-02
00840194499224Contracture ManagementNS-6000-3004NS-6000-30042026-03-02
00840194499231Contracture ManagementNS-6000-3005NS-6000-30052026-03-02
00840194499248Contracture ManagementNS-6000-4001NS-6000-40012026-03-02
00840194499255Contracture ManagementNS-6000-4101NS-6000-41012026-03-02
00840194499262Contracture ManagementNS-6000-4002NS-6000-40022026-03-02
00840194499279Contracture ManagementNS-6000-4102NS-6000-41022026-03-02
00840194498968Response Spine System01-1600-559001-1600-55902026-01-29
00840194498128Response Spine System01-1300-091001-1300-09102026-01-22
00840194498043Response Spine System01-1300-551601-1300-55162026-01-15
00840194498050Response Spine System01-1300-551701-1300-55172026-01-15
00840194498944Response 5.5/6.001-1300-607301-1300-60732026-01-15
00840194498951Response 5.5/6.001-1300-607401-1300-60742026-01-15
00840536800237Response Spine System01-1700-028001-1700-02802026-01-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840493416540LUX Expandable Interbody SystemXENIX MEDICAL LLCHXC2026-03-13
00888867500785Arthrex®ARTHREX, INC.HXC2026-03-13
00888867500808Arthrex®ARTHREX, INC.HXC2026-03-13
00888867500815Arthrex®ARTHREX, INC.HXC2026-03-13
00888867500853Arthrex®ARTHREX, INC.HXC2026-03-13
00199150065974Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXC2026-02-28
00190376731988IdentiTi IIALPHATEC SPINE, INC.HXC2026-02-18
03662663131636Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2026-02-11
03662663131643Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2026-02-11
03662663131650Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2026-02-11
00840180543948General InstrumentsALPHATEC SPINE, INC.HXC2025-12-31
03662663198202Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHXC2025-12-17
03662663216760Nex-Link OCT Occipital Cervical Plating SystemHighridge Medical, LLCHXC2025-12-17
03662663216777Nex-Link OCT Occipital Cervical Plating SystemHighridge Medical, LLCHXC2025-12-17
03662663191906Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2025-12-16
03662663136549Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2025-11-14
03662663136556Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2025-11-14
03662663136563Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2025-11-14
03662663137249Polaris 4.75 Deformity SystemHighridge Medical, LLCHXC2025-11-14
03662663161466The Tether Vertebral Body Tethering SystemHighridge Medical, LLCHXC2025-11-14
03662663192385InCompass Spinal Fixation SystemHighridge Medical, LLCHXC2025-11-14
03662663194129PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCHXC2025-11-14
00199150051199Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXC2025-11-13
00840314269768gSourceGSOURCE LLCHXC2025-08-29
00889797111195Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00889797111201Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00889797111218Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00889797111225Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00889797112642N/AWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00194613018528MSI Precision Specialty InstrumentsMed Saver, Inc.HXC2025-08-01