FDA.reportPublic FDA data

OXFORD ANKLE FUSION NAIL(AFN) SYSTEM

Primary DI
05055662928686
Brand
OXFORD ANKLE FUSION NAIL(AFN) SYSTEM
Company
ORTHO SOLUTIONS HOLDINGS LIMITED
Model
OS333522
Catalog number
OS333522
Device description
5MM DRILL GUIDE
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
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
05055662928686PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055662928686050556629286865055662928686

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. 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
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
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

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