FDA.reportPublic FDA data

Response Spine System

Primary DI
00840194444903
Brand
Response Spine System
Company
ORTHOPEDIATRICS CORP.
Model
01-1301-9010
Catalog number
01-1301-9010
Device description
5.5/6.0 Power CANNULATED Pedicle Screw Driver, 140MM
Published
2024-02-23
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
KIJInstrument, surgical, orthopedic, dc-powered motor and accessory/attachment

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840194444903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194444903008401944449038401944449030840194444903

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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
00840536822543Prone Perfect03-1300-880103-1300-88012026-05-22
00840536822550Prone Perfect03-1300-880203-1300-88022026-05-22
00840536822567Prone Perfect03-1300-880303-1300-88032026-05-22
00840536822574Prone Perfect03-1300-880403-1300-88042026-05-22
00840536822581Prone Perfect03-1300-880503-1300-88052026-05-22
00840536822598Prone Perfect03-1300-880603-1300-88062026-05-22
00840536822604Prone Perfect03-1300-880703-1300-88072026-05-22
00840536822611Prone Perfect03-1300-880803-1300-88082026-05-22
00840536822628Prone Perfect03-1300-880903-1300-88092026-05-22
00840536822635Prone Perfect03-1300-881003-1300-88102026-05-22
00840536822642Prone Perfect03-1300-881103-1300-88112026-05-22
00841132199244OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6000-S00-1200-6000-S2026-05-13
00841132199251OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6001-S00-1200-6001-S2026-05-13
00841132199268OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6002-S00-1200-6002-S2026-05-13
00841132199275OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6003-S00-1200-6003-S2026-05-13
00841132199282OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6004-S00-1200-6004-S2026-05-13
00841132199299OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6005-S00-1200-6005-S2026-05-13
00841132199305OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6006-S00-1200-6006-S2026-05-13
00841132199312OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6014-S00-1200-6014-S2026-05-13
00841132199329OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6015-S00-1200-6015-S2026-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809260475649TRAUS SSG40Saeshin Precision Co., Ltd.KIJ2026-05-19
08800038060807EZImpactorIMEDICOM CO., LTD.KIJ2026-04-21
08800038060814EZImpactorIMEDICOM CO., LTD.KIJ2026-04-21
08809260473812TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473829TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473836TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473843TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473850TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473867TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473874TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473881TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473898TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473904TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473911TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260474598TRAUS SSG20Saeshin Precision Co., Ltd.KIJ2026-04-09
08809260475182TRAUS SSG40Saeshin Precision Co., Ltd.KIJ2026-04-09
08809260475526SSG20Saeshin Precision Co., Ltd.KIJ2026-04-09
08809260475533SSG40Saeshin Precision Co., Ltd.KIJ2026-04-09
08809260475540SSG40Saeshin Precision Co., Ltd.KIJ2026-04-09
08809260475557SSG40Saeshin Precision Co., Ltd.KIJ2026-04-09
08800038060784EZImpactorIMEDICOM CO., LTD.KIJ2026-04-01
08800038060791EZImpactorIMEDICOM CO., LTD.KIJ2026-04-01
10603295559511INHANCE INTACTDEPUY (IRELAND)KIJ2025-06-13
10603295559597INHANCE INTACTDEPUY (IRELAND)KIJ2025-06-13
10603295559771INHANCE INTACTDEPUY (IRELAND)KIJ2025-06-13
10603295559801INHANCE INTACTDEPUY (IRELAND)KIJ2025-06-13
10603295559825INHANCE INTACTDEPUY (IRELAND)KIJ2025-06-13
00840286841603Consensus Hip SystemShalby Advanced Technologies, Inc.KIJ2025-05-22
00840286841610Consensus Hip SystemShalby Advanced Technologies, Inc.KIJ2025-05-22
00840286841627Consensus Hip SystemShalby Advanced Technologies, Inc.KIJ2025-05-22