FDA.reportPublic FDA data

NA

Primary DI
03596010532695
Brand
NA
Company
Smith & Nephew, Inc.
Model
71928166
Catalog number
71928166
Device description
PIN INSERTER/EXTRACTOR
Published
2015-08-29
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
K120871000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120871000SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.2012-06-07JDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010532695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010532695035960105326953596010532695

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com
+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