FDA.reportPublic FDA data

Response Spine System

Primary DI
00840194445009
Brand
Response Spine System
Company
ORTHOPEDIATRICS CORP.
Model
01-1300-8160
Catalog number
01-1300-8160
Device description
6.0mm Solid Tap, Single Lead, 140mm
Published
2024-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWXTAP, BONE
KIJInstrument, surgical, orthopedic, dc-powered motor and accessory/attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840194445009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194445009008401944450098401944450090840194445009

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
796416191
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841132133200PediFlex01-1000-00101-1000-0012017-02-15
00841132133217PediFlex01-1000-00201-1000-0022017-02-15
00841132135280PediNail21-1500-00721-1500-0072017-02-15
00841132135297PediNail21-1500-01021-1500-0102017-02-15
00841132135303PediNail21-1500-01221-1500-0122017-02-15
00841132135310PediNail21-1500-01321-1500-0132017-02-15
00841132135334PediNail21-1500-01921-1500-0192017-02-15
00841132135341PediNail21-1500-11221-1500-1122017-02-15
00841132135358PediNail21-1500-11921-1500-1192017-02-15
00841132135372PediNail21-1500-911321-1500-91132017-02-15
00841132135389PediNail21-1500-921321-1500-92132017-02-15
00841132135396PediNail21-1500-921421-1500-92142017-02-15
00841132179833Vilex ToolP460-45-100P460-45-1002020-03-02
00841132179888Orthex ToolPP460-15-110PP460-15-1102020-03-02
00841132142325eZ-Fix500-G500-G2020-02-28
00841132142905eZ-Fix900-CW-14900-CW-142020-02-28
00841132142950eZ-Fix900-TW-30900-TW-302020-02-28
00841132143025eZ-Fix925-TW-30925-TW-302020-02-28
00841132125014General Instrument01-1003-300101-1003-30012016-09-25
00841132125021General Instrument01-1003-300201-1003-30022016-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008401944957693P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIJ2026-06-10
008401944957763P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIJ2026-06-10
008401944958063P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIJ2026-06-10
008401944961003P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIJ2026-06-10
008401944963773P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIJ2026-06-10
008401944966433P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIJ2026-06-10
008401944969193P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIJ2026-06-10
08809260475649TRAUS SSG40Saeshin Precision Co., Ltd.KIJ2026-05-19
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
G079C5020001000Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
G079C5020001050Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
08800038060807EZImpactorIMEDICOM CO., LTD.KIJ2026-04-21
08800038060814EZImpactorIMEDICOM CO., LTD.KIJ2026-04-21
08800322758182Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08800322758199Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08800322758205Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08800322758212Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08800322758229Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08800322758243Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08800322758250Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21