FDA.reportPublic FDA data

Response 5.5/6.0 Spine System

Primary DI
00841132124062
Brand
Response 5.5/6.0 Spine System
Company
ORTHOPEDIATRICS CORP.
Model
01-1003-6044
Catalog number
01-1003-6044
Device description
4.0MM TAP, 25MM LENGTH, HUDSON
Published
2020-03-05
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
HWXTAP, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841132124062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132124062008411321240628411321240620841132124062

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
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
796416191
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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
08800308479070ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HWX2026-08-19
08800308479094ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HWX2026-08-19
08800308479117ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HWX2026-08-19
00840606191883Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606191890Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606191906Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606195782Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606195799Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606195805Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606195812Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
07290019361343OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361350OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361367OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361374OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361381OSSIO® TapOSSIO LTDHWX2026-07-19
18257200076581CETRAOrthofix US LLCHWX2026-07-17
18257200076604CETRAOrthofix US LLCHWX2026-07-17
18257200076611CETRAOrthofix US LLCHWX2026-07-17
18257200076628CETRAOrthofix US LLCHWX2026-07-17
09120125220280Shark Screw® tapsurgebright GmbHHWX2026-04-30
10705034577913N/AMedos International SàrlHWX2026-04-23
10705034577920N/AMedos International SàrlHWX2026-04-23
10705034577937N/AMedos International SàrlHWX2026-04-23
10705034577944N/AMedos International SàrlHWX2026-04-23
10705034577951N/AMedos International SàrlHWX2026-04-23
10705034577968N/AMedos International SàrlHWX2026-04-23
10705034577975N/AMedos International SàrlHWX2026-04-23
10705034577982N/AMedos International SàrlHWX2026-04-23
10705034577999N/AMedos International SàrlHWX2026-04-23
G079C5020000950Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22