FDA.reportPublic FDA data

PERI-LOC

Primary DI
00885556116272
Brand
PERI-LOC
Company
Smith & Nephew, Inc.
Model
71177157
Catalog number
71177157
Device description
6.5MM / 8.0MM SCREW CAPTURE SLEEVE
Published
2022-03-04
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
HRSPlate, fixation, bone
HTYPIN, FIXATION, SMOOTH
HWCScrew, fixation, bone
JDODEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HTYPin, Fixation, SmoothOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
JDODevice, Fixation, Proximal Femoral, ImplantOrthopedic2

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
00885556116272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556116272008855561162728855561162720885556116272

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. 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
008405368000393P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000463P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000533P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000603P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
08809986479938CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
08809986479945CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
10850070500125CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500132CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500149CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500156CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500163CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500170CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500187CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500194CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500200CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500217CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500224CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500231CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500248CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500255CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500262CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500279CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500286CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500293CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500309CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500316CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500323CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500330CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500347CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500354CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22