FDA.reportPublic FDA data

OXFORD ANKLE FUSION NAIL(AFN) SYSTEM

Primary DI
05055662928648
Brand
OXFORD ANKLE FUSION NAIL(AFN) SYSTEM
Company
ORTHO SOLUTIONS HOLDINGS LIMITED
Model
OS333024
Catalog number
OS333024
Device description
OXFORD ANKLE FUSION NAIL T-HANDLE
Published
2017-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

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
05055662928648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055662928648050556629286485055662928648

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic trocar blade, reusableA rigid hand-held surgical instrument with a sharp (pyramidal or conical) point designed to be used during orthopaedic surgery for the manual puncture of a bodily entry point to: 1) gently part the surrounding soft tissue upon entry; 2) assist in the location and positioning of skeletal fractures; and/or 3) assist alignment of surgical instruments/implants. It is typically made of high-grade stainless steel, titanium (Ti), or synthetic material. This is a reusable device.

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
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

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G4533312BT0PEAK MEDICALPeak Medical Distribution Inc.LXH2026-06-03
07613327648355PANGEAStryker GmbHLXH2026-06-02
07613327648379PANGEAStryker GmbHLXH2026-06-02
00199150077359Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
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