FDA.reportPublic FDA data

General Instrument

Primary DI
00841132125465
Brand
General Instrument
Company
ORTHOPEDIATRICS CORP.
Model
01-1003-6152
Catalog number
01-1003-6152
Device description
Hook Holder, Straight Closed
Published
2016-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTDFORCEPS
KIKHOOK, BONE
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1
KIKHook, BoneGeneral, Plastic Surgery1
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841132125465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132125465008411321254658411321254650841132125465

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(574)268-6379bsmith@orthopediatric.com

Regulatory Flags#

DUNS number
796416191
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817867021044PNP Femur00-1560-716000-1560-71602026-10-01
00817867021051PNP Femur00-1560-716500-1560-71652026-10-01
00817867021068PNP Femur00-1560-717000-1560-71702026-10-01
00817867021075PNP Femur00-1560-717500-1560-71752026-10-01
00817867021082PNP Femur00-1560-718000-1560-71802026-10-01
00817867021099PNP Femur00-1560-718500-1560-71852026-10-01
00817867021105PNP Femur00-1560-719000-1560-71902026-10-01
00817867021112PNP Femur00-1560-719500-1560-71952026-10-01
00817867021129PNP Femur00-1560-720000-1560-72002026-10-01
00817867021136PNP Femur00-1560-720500-1560-72052026-10-01
00817867021143PNP Femur00-1560-721000-1560-72102026-10-01
00817867021150PNP Femur00-1560-721500-1560-72152026-10-01
00817867021167PNP Femur00-1560-722000-1560-72202026-10-01
00817867021174PNP Femur00-1560-722500-1560-72252026-10-01
00817867021181PNP Femur00-1560-723000-1560-72302026-10-01
00817867021198PNP Femur00-1560-723500-1560-72352026-10-01
00817867021204PNP Femur00-1560-724000-1560-72402026-10-01
00817867021211PNP Femur00-1560-724500-1560-72452026-10-01
00817867021228PNP Femur00-1560-725000-1560-72502026-10-01
00817867021235PNP Femur00-1560-725500-1560-72552026-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G141510443190Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G141511368200Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G141511368300Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G14151423610Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G14152810910Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G14154212860Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
M711620155550Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-09-30
10888857598256Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598263Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598270Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598287Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598294Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598300Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598317Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598324Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598331Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598348Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598355Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598362Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598379Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598386Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598393Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598409Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598416Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598423Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598430Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598447Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598454Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598461Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598478Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24