FDA.report

Sterile Spine Pedicle Screw System

Primary DI
B5627720640
Brand
Sterile Spine Pedicle Screw System
Company
WISHBONE MEDICAL, INC.
Model
77.2064
Catalog number
77.2064
Device description
Handle, Axial, Ratchet, AO
Published
2023-02-02
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
true

Related Records

Contact Domains

Product Codes

CodeName
HXCWrench

Product Code Classifications

CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B5627720640PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical torque wrench, reusableA hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
(574) 306-4006CustomerService@wishbonemedical.com

Regulatory Flags

DUNS number
062355158
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
true
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
B562PKGS000100Micro Surgery KitPK-GS0001PK-GS00012024-12-30
B562PKGS000200Minor Surgery KitPK-GS0002PK-GS00022024-12-30
B56251300MDG000G10WishBone Plate & Screw System51-300-MDG000G-151-300-MDG000G-12024-01-01
B56211705310200S0Smart Correction11-705-310200S11-705-310200S2023-06-23
B56211705315200S0Smart Correction11-705-315200S11-705-315200S2023-06-23
B56211705320200S0Smart Correction11-705-320200S11-705-320200S2023-06-23
B56211705325200S0Smart Correction11-705-325200S11-705-325200S2023-06-23
B56211705330200S0Smart Correction11-705-330200S11-705-330200S2023-06-23
B56211705335200S0Smart Correction11-705-335200S11-705-335200S2023-06-23
B56211705340200S0Smart Correction11-705-340200S11-705-340200S2023-06-23
B56211705345200S0Smart Correction11-705-345200S11-705-345200S2023-06-23
B56211705350200S0Smart Correction11-705-350200S11-705-350200S2023-06-23
B56211705410200S0Smart Correction11-705-410200S11-705-410200S2023-06-23
B56211705415200S0Smart Correction11-705-415200S11-705-415200S2023-06-23
B56211705420200S0Smart Correction11-705-420200S11-705-420200S2023-06-23
B56211705425200S0Smart Correction11-705-425200S11-705-425200S2023-06-23
B56211705430200S0Smart Correction11-705-430200S11-705-430200S2023-06-23
B56211705435200S0Smart Correction11-705-435200S11-705-435200S2023-06-23
B56211705440200S0Smart Correction11-705-440200S11-705-440200S2023-06-23
B56211705445200S0Smart Correction11-705-445200S11-705-445200S2023-06-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840493416540LUX Expandable Interbody SystemXENIX MEDICAL LLCHXC2026-03-13
00888867500785Arthrex®ARTHREX, INC.HXC2026-03-13
00888867500808Arthrex®ARTHREX, INC.HXC2026-03-13
00888867500815Arthrex®ARTHREX, INC.HXC2026-03-13
00888867500853Arthrex®ARTHREX, INC.HXC2026-03-13
00199150065974Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXC2026-02-28
00190376731988IdentiTi IIALPHATEC SPINE, INC.HXC2026-02-18
03662663131636Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2026-02-11
03662663131643Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2026-02-11
03662663131650Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2026-02-11
00840180543948General InstrumentsALPHATEC SPINE, INC.HXC2025-12-31
03662663198202Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHXC2025-12-17
03662663216760Nex-Link OCT Occipital Cervical Plating SystemHighridge Medical, LLCHXC2025-12-17
03662663216777Nex-Link OCT Occipital Cervical Plating SystemHighridge Medical, LLCHXC2025-12-17
03662663191906Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2025-12-16
03662663136549Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2025-11-14
03662663136556Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2025-11-14
03662663136563Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2025-11-14
03662663137249Polaris 4.75 Deformity SystemHighridge Medical, LLCHXC2025-11-14
03662663161466The Tether Vertebral Body Tethering SystemHighridge Medical, LLCHXC2025-11-14
03662663192385InCompass Spinal Fixation SystemHighridge Medical, LLCHXC2025-11-14
03662663194129PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCHXC2025-11-14
00199150051199Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXC2025-11-13
00840314269768gSourceGSOURCE LLCHXC2025-08-29
00889797111195Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00889797111201Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00889797111218Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00889797111225Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00889797112642N/AWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00194613018528MSI Precision Specialty InstrumentsMed Saver, Inc.HXC2025-08-01