FDA.reportPublic FDA data

OXFORD ANKLE FUSION NAIL(AFN) SYSTEM

Primary DI
05055662928570
Brand
OXFORD ANKLE FUSION NAIL(AFN) SYSTEM
Company
ORTHO SOLUTIONS HOLDINGS LIMITED
Model
OS333017
Catalog number
OS333017
Device description
OXFORD AFN DEPTH GAUGE
Published
2017-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTJGauge, Depth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTJGauge, DepthOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121575000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121575000OXFORD ANKLE FUSION NAIL(AFN) SYSTEMOrtho Solutions Limited2012-09-14HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055662928570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055662928570050556629285705055662928570

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+441621843599quality@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
00190776435509MillenniumAvalign Technologies, Inc.HTJ2026-10-20
04719886915273U-Motion IIUNITED ORTHOPEDIC CORP.HTJ2026-10-15
10886982345455VOLTSynthes GmbHHTJ2026-09-25
00840606191609Overwatch PCFSPINAL ELEMENTS, INC.HTJ2026-07-31
03700569674250Newclip InstrumentsNEWCLIP TECHNICSHTJ2026-07-27
03700569674274Newclip InstrumentsNEWCLIP TECHNICSHTJ2026-07-27
00842188130311Tools - ScrewsTrimed, INC.HTJ2026-07-22
06974940307243endophixSuzhou Endophix Co., Ltd.HTJ2026-06-23
08809513720045SAEHAN Hydraulic Pinch GaugeSaehan CorporationHTJ2026-05-18
08809513720359SAEHAN Mechanical Pinch GaugeSaehan CorporationHTJ2026-05-18
08800322750001AnyPlus®GS Medical Co., Ltd.HTJ2026-04-21
00810112597486TriLEAPSynthes GmbHHTJ2026-02-10
10850070500484Cannulated Depth Guage CURVAFIX, INC.HTJ2025-10-22
00810135963404ImpactNVision Biomedical Technologies, Inc.HTJ2025-09-24
05055662971057ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHTJ2025-08-15
08800071006862Surgical InstrumentOSTEONIC CO.,Ltd.HTJ2025-06-24
08809539690667Surgical InstrumentOSTEONIC CO.,Ltd.HTJ2025-06-24
10840199512703Depth GaugeKOROS U.S.A., INC.HTJ2024-12-31
10840199513670Multi Level Black Belt Depth GaugeKOROS U.S.A., INC.HTJ2024-12-31
00810112597936MOTOBAND InstrumentsCROSSROADS EXTREMITY SYSTEMSHTJ2024-07-31
00810112592542TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTJ2024-02-23
00810112592702TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTJ2024-02-23
00810112592719TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTJ2024-02-23
10885862573483EPICExactech, Inc.HTJ2024-01-08
B56251300MDG000G10WishBone Plate & Screw SystemWishbone Medical, Inc.HTJ2024-01-01
07708604560472SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHTJ2023-01-18
08055727374561DEPTH GAUGE 9 mmHPF SRLHTJ2022-12-09
08055727374578DEPTH GAUGE 9 mmHPF SRLHTJ2022-12-09
10603295550273INHANCEDEPUY (IRELAND)HTJ2022-12-09
10855068008607Implant Selection DeviceCURVAFIX, INC.HTJ2022-12-05