FDA.reportPublic FDA data

ORTHO SOLUTIONS SUCCESSION AFN SYSTEM

Primary DI
05055662970524
Brand
ORTHO SOLUTIONS SUCCESSION AFN SYSTEM
Company
ORTHO SOLUTIONS HOLDINGS LIMITED
Model
OS353025-NS
Catalog number
OS353025-NS
Device description
AXIAL RATCHETING CANNULATED HANDLE - HUDSON QC
Published
2025-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250622000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250622000Succession™ AFN SystemOrtho Solutions UK , Ltd.2025-08-07HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055662970524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055662970524050556629705245055662970524

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4401621874378regulatory@orthosol.com

Regulatory Flags#

DUNS number
218648211
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055662922622Volition™ Plating SystemOS900091-NSOS900091-NS2026-10-16
05055662966855Volition™ Plating SystemOS720000A-NSOS720000A-NS2026-10-16
05055662966862Volition™ Plating SystemOS720000B-NSOS720000B-NS2026-10-16
05055662968538Volition™ Plating SystemOS740224-NSOS740224-NS2026-10-16
05055662969641ORTHO SOLUTIONS VOLITION PLATING SYSTEMOS720012OS720012-NS2023-10-31
05055662969474ORTHO SOLUTIONS VOLITION PLATING SYSTEMOS733114LOS733114L-NS2023-03-17
05055662976649Volition™ Plating SystemOS731052R-NSOS731052R-NS2026-10-06
05055662976656Volition™ Plating SystemOS731052L-NSOS731052L-NS2026-10-06
05055662976663Volition™ Plating SystemOS731043-NSOS731043-NS2026-10-06
05055662976670Volition™ Plating SystemOS731022R-NSOS731022R-NS2026-10-06
05055662976687Volition™ Plating SystemOS731022L-NSOS731022L-NS2026-10-06
05055662963489Volition™ Plating SystemOS731051R-NSOS731051R-NS2021-06-25
05055662963496Volition™ Plating SystemOS731051L-NSOS731051L-NS2021-06-25
05055662971057ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353017-NSOS353017-NS2025-08-15
05055662970890ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS355038-SOS355038-S2026-07-10
05055662971514ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356075-SOS356075-S2026-07-10
05055662968545OrthoSolutions 'System26' Bone ScrewsOS900106-NSOS900106-NS2026-06-24
05055662971361ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353018-NSOS353018-NS2026-04-09
05055662971378ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353103-SOS353103-S2026-04-09
05055662971385ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353103L-SOS353103L-S2026-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD91449311010Surgical DirectSurgical Direct, Inc.HXX2026-10-28
08800089487820Surgical InstrumentJeil Medical CorporationHXX2026-10-26
00190776436933MillenniumAvalign Technologies, Inc.HXX2026-10-23
09120125220242Shark Screw® driver cutsurgebright GmbHHXX2026-10-22
00199150076451Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080373Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080380Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080397Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00824846013600Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00889024709164CANNULATED 1.5MM HEX DRIVERZimmer, Inc.HXX2026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERZimmer, Inc.HXX2026-10-19
M697X06402401Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.HXX2026-10-14
B382SD1455810020Surgical DirectSurgical Direct, Inc.HXX2026-09-29
B382SD1455810030Surgical DirectSurgical Direct, Inc.HXX2026-09-29
10886982345462VOLTSynthes GmbHHXX2026-09-25
00840606197342OmegaSPINAL ELEMENTS, INC.HXX2026-09-22
07640139343185BAGUERA C INSTRUMENTATIONSpineArt SAHXX2026-08-27
00843210143644Monaco Pedicle Screw SystemAltus Spine, LLCHXX2026-08-24
00199150083091Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-22
B095329646Hintermann SeriesDt Medtech, LLCHXX2026-08-21
00199150083459Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-08
00199150083466Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-08
00199150076468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-03
00199150076475Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-03
00840606191616Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191623Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191746Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191753Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191784Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191944Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31