FDA.reportPublic FDA data

OXFORD ANKLE FUSION NAIL(AFN) SYSTEM

Primary DI
05055662917772
Brand
OXFORD ANKLE FUSION NAIL(AFN) SYSTEM
Company
ORTHO SOLUTIONS HOLDINGS LIMITED
Model
OS332150R
Catalog number
OS332150R
Device description
OXFORD ANKLE FUSION NAIL 12MM X 150MM (Ti6Al4V)
Published
2016-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

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
05055662917772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055662917772050556629177725055662917772

GMDN Terms#

Term, Definition table
TermDefinition
Arthrodesis nail, sterileA sterile rod made of metal or other material (e.g., carbon fibre) designed to be inserted into the intramedullary canal of any long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), talus, fibula, radius, ulna] to immobilize by holding the ends of a fractured or diseased bone together (i.e., in position) for the purpose of joint fusion or arthrodesis (an operation to permanently fix a joint in position). The device is used for traumatic repair or reconstructive procedures; it may include screws if locked into place. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441621843599quality@orthosol.com

Regulatory Flags#

DUNS number
218648211
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05055662971392ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353104-SOS353104-S2026-04-09
05055662971408ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353113-SOS353113-S2026-04-09
05055662971415ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS355055-SOS355055-S2026-04-09
05055662971422ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS355060-SOS355060-S2026-04-09
05055662971439ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS355065-SOS355065-S2026-04-09
05055662971446ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS355070-SOS355070-S2026-04-09
05055662971453ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356045-SOS356045-S2026-04-09
05055662971460ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356050-SOS356050-S2026-04-09
05055662971477ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356055-SOS356055-S2026-04-09
05055662971484ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356060-SOS356060-S2026-04-09
05055662971491ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356065-SOS356065-S2026-04-09
05055662971507ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356070-SOS356070-S2026-04-09
05055662971521ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356080-SOS356080-S2026-04-09
05055662971538ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356115-SOS356115-S2026-04-09
05055662971545ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356120-SOS356120-S2026-04-09
05055662971552Volition™ Plating SystemOS731019L-NSOS731019L-NS2026-03-04
05055662971569Volition™ Plating SystemOS731019R-NSOS731019R-NS2026-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B058AHN08165L1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
B058AHN08165R1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
10855068008423Lock ActivatorCURVAFIX, INC.HSB2022-06-20
10855068008492Inserter/ExtractorCURVAFIX, INC.HSB2022-06-20
10855068008539Sterilization Case, OuterCURVAFIX, INC.HSB2022-06-20
10855068008621Ring Lock, Long InserterCURVAFIX, INC.HSB2022-06-20
10855068008003CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008010CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008027CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008034CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008041CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008058CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008065CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008072CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008089CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008096CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008102CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
07898624869669NEONAIL Neoortho Produtos Ortopédicos S/A.HSB2015-10-21
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