FDA.reportPublic FDA data

Ex-Fix

Primary DI
00885556885192
Brand
Ex-Fix
Company
Smith & Nephew, Inc.
Model
E0017815-1
Catalog number
E0017815-1
Device description
SHORTENED 155 2/3 RING
Published
2022-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDWPIN, FIXATION, THREADED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDWPin, Fixation, ThreadedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K994143000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994143000SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]Smith & Nephew, Inc.2000-02-18JDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556885192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556885192008855568851928855568851920885556885192

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, single-useAn assembly of devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556925690NAROB30080ROB300802026-06-04
03596010589101JOURNEY71422274714222742015-08-30
03596010589132JOURNEY71422277714222772015-08-30
03596010000675OXINIUM71343603713436032015-08-30
03596010474148OXINIUM71342800713428002015-08-30
03596010474162OXINIUM71342804713428042015-08-30
03596010474179OXINIUM71342808713428082015-08-30
03596010474209OXINIUM71343200713432002015-08-30
03596010474216OXINIUM71343203713432032015-08-30
03596010474223OXINIUM71343204713432042015-08-30
03596010474230OXINIUM71343208713432082015-08-30
03596010477279OXINIUM71343600713436002015-08-30
03596010477286OXINIUM71343604713436042015-08-30
03596010477293OXINIUM71343608713436082015-08-30
03596010488862OXINIUM71342200713422002015-08-30
03596010544193JOURNEY71461012714610122015-08-30
03596010544209JOURNEY71461013714610132015-08-30
03596010544216JOURNEY71461014714610142015-08-30
03596010544223JOURNEY71461015714610152015-08-30
03596010544230JOURNEY71461016714610162015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059386747407DOLPHIXCITIEFFE SRLJDW2025-04-02
08052990971893DOLPHIXCITIEFFE SRLJDW2024-10-28
08032909624256ST.A.R. 90 F4CITIEFFE SRLJDW2024-09-11
08905892004599GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004605GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004612GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004629GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004636GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004643GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004650GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004667GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004674GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004681GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004698GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004704GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004711GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004728GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004735GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004742GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004759GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004766GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004773GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004780GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004568GPCGPC MEDICAL LIMITEDJDW2023-12-30
08905892004575GPCGPC MEDICAL LIMITEDJDW2023-12-30
08720629950556ANSER Clavicle PinBaat Medical Products B.V.JDW2022-12-14
08720629950563ANSER Clavicle PinBaat Medical Products B.V.JDW2022-12-14
08720629950570ANSER Clavicle PinBaat Medical Products B.V.JDW2022-12-14
08720629950587ANSER Clavicle PinBaat Medical Products B.V.JDW2022-12-14
08720629950594ANSER Clavicle PinBaat Medical Products B.V.JDW2022-12-14