FDA.reportPublic FDA data

ANTHOLOGY

Primary DI
00885556913406
Brand
ANTHOLOGY
Company
Smith & Nephew, Inc.
Model
E0018160-1
Catalog number
E0018160-1
Device description
LOCKING QUICK CONNECT T-HANDLE
Published
2023-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDGProsthesis, hip, femoral component, cemented, metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDGProsthesis, Hip, Femoral Component, Cemented, MetalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123598000SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.2013-06-28JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556913406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556913406008855569134068855569134060885556913406

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable 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
00885554009101NA720770572077052015-08-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327383430ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383454ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383461ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383485ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383515ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383522ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383553ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383591ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383614ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383621ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383676ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383706ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383713ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383737ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383744ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383751ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383805ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383812ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383836ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383843ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383904ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383911ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327123852V40Howmedica Osteonics Corp.JDG2018-06-13
07613327123739EXETERHowmedica Osteonics Corp.JDG2018-05-03
07613327123746EXETERHowmedica Osteonics Corp.JDG2018-05-03
07613327123753EXETERHowmedica Osteonics Corp.JDG2018-05-03
07613327123777EXETERHowmedica Osteonics Corp.JDG2018-05-03
07613327123791EXETERHowmedica Osteonics Corp.JDG2018-05-03
07613327123845EXETERHowmedica Osteonics Corp.JDG2018-05-03