FDA.reportPublic FDA data

Peri-Loc

Primary DI
03596010538574
Brand
Peri-Loc
Company
Smith & Nephew, Inc.
Model
71173384
Catalog number
71173384
Device description
PERI-LOC TARGETER LARGE FRAGMENT K-WIRE GUIDE
Published
2015-08-25
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
HRSPLATE, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123055000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123055000SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.2013-01-25HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010538574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010538574035960105385743596010538574

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, cerclage wire/cable, non-sterileA non-sterile assembly of implantable devices designed for general orthopaedic repairs including procedures for long bone fractures, hips, spine, bone grafting and reinforcement of bone. It may also be used for supplementary fixation and reduction with bone plate/screw systems. It typically consists of cerclage wires or cables and crimps and/or clamps made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy). It may also include instruments for the attachment of the implants such as crimping tool, cerclage wire/cable cutting tool, a tensioning tool, and a passer. This device is intended to be sterilized prior to use.

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
03596010194534SYNERGY71306709713067092015-08-30
03596010194541SYNERGY71306710713067102015-08-30
03596010194558SYNERGY71306711713067112015-08-30
03596010194565SYNERGY71306712713067122015-08-30
03596010194572SYNERGY71306713713067132015-08-30
03596010194589SYNERGY71306714713067142015-08-30
03596010194596SYNERGY71306715713067152015-08-30
03596010194602SYNERGY71306716713067162015-08-30
03596010194619SYNERGY71306717713067172015-08-30
03596010194626SYNERGY71306718713067182015-08-30
03596010384935SYNERGY71306409713064092015-08-29
03596010384942SYNERGY71306410713064102015-08-29
03596010384966SYNERGY71306411713064112015-08-29
03596010384973SYNERGY71306412713064122015-08-29
03596010384980SYNERGY71306413713064132015-08-30
03596010384997SYNERGY71306414713064142015-08-30
03596010385000SYNERGY71306415713064152015-08-30
03596010385017SYNERGY71306416713064162015-08-30
03596010385024SYNERGY71306417713064172015-08-30
03596010385031SYNERGY71306418713064182015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986490001CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490018CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490025CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490032CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490049CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490056CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490063CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490087CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490094CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490100CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490117CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490124CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490131CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490148CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490155CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490162CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490179CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490186CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490193CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490209CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490216CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490223CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490230CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490247CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490254CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490261CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490278CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490285CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490292CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490308CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27