FDA.report

OP Response Spine System

Primary DI
00840194445849
Brand
OP Response Spine System
Company
ORTHOPEDIATRICS CORP.
Model
01-1301-6043
Catalog number
01-1301-6043
Device description
5.5/6.0 Closed Pedicle screw driver, T20, Zimmer Hudson
Published
2023-04-30
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
GFCDRIVER, SURGICAL, PIN

Product Code Classifications

CodeDeviceSpecialtyClass
GFCDriver, Surgical, PinGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840194445849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194445849008401944458498401944458490840194445849

GMDN Terms

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
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
00842188130304K-WiresTrimed, INC.GFC2025-07-08
00841132197066PediNailORTHOPEDIATRICS CORP.GFC2025-06-05
00840194472401PNP FemurORTHOPEDIATRICS CORP.GFC2025-05-28
00840286842129Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286842136Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286846714Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855044Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855051Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855068Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855136Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855143Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855150Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855167Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286859950Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286843867UniSyn Hip SystemShalby Advanced Technologies, Inc.GFC2025-05-20
14053613292136PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613292143PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613292150PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613292167PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
04053613293167PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-15
00840286846707Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-14
04042409452987NAaap Implantate AGGFC2025-02-26
04042409453007NAaap Implantate AGGFC2025-02-26
04042409453021NAaap Implantate AGGFC2025-02-26
04042409453045NAaap Implantate AGGFC2025-02-26
10886982347459NASynthes GmbHGFC2024-08-14
00840194478427Broken Screw Removal InstrumentsORTHOPEDIATRICS CORP.GFC2024-08-07
00840194478434Broken Screw Removal InstrumentsORTHOPEDIATRICS CORP.GFC2024-08-07
00840194478458Broken Screw Removal InstrumentsORTHOPEDIATRICS CORP.GFC2024-08-07
00840194478472Broken Screw Removal InstrumentsORTHOPEDIATRICS CORP.GFC2024-08-07