FDA.reportPublic FDA data

Peri-Loc

Primary DI
00885556882375
Brand
Peri-Loc
Company
Smith & Nephew, Inc.
Model
XT001176-1
Catalog number
XT001176-1
Device description
4.5MM POSTERIOR DISTAL TIBIA LOCKING PLATE 5 HOLE RIGHT
Published
2022-07-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K092015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092015000PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEMSmith & Nephew, Inc.2009-07-30HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556882375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556882375008855568823758855568823750885556882375

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, non-sterileA non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). 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
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556838211Total Foot System 2280500728050072023-04-18
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15
00885556572368NA72201598S72201598S2017-06-15
00885556830543PyroCarbon Modular Radial HeadTRL-310-01TRL-310-012026-09-24
00885556830550PyroCarbon Modular Radial HeadTRL-310-02TRL-310-022026-09-24
00885556830567PyroCarbon Modular Radial HeadTRL-310-03TRL-310-032026-09-24
00885556830574PyroCarbon Modular Radial HeadTRL-310-04TRL-310-042026-09-24
00885556839690Total Foot System 2CSA-800-06CSA-800-062026-09-24
00885556839706Total Foot System 2CSA-800-07CSA-800-072026-09-24
00885556854778Cadence Total Ankle SystemCSA-1020-0014CSA-1020-00142026-09-24
00885556859636Titan Modular Shoulder SystemCSA092009CSA0920092026-09-24
00885556859643Titan Modular Shoulder SystemCSA092010CSA0920102026-09-24
00885556859650Titan Modular Shoulder SystemCSA092011CSA0920112026-09-24
00885556859698Titan Modular Shoulder SystemCSA-0920-15CSA-0920-152026-09-24
00885556859704Titan Modular Shoulder SystemCSA-0920-16CSA-0920-162026-09-24
00885556859711Titan Modular Shoulder SystemCSA-0920-17CSA-0920-172026-09-24
00885556859728Titan Modular Shoulder SystemCSA-0920-18CSA-0920-182026-09-24
00885556859735Titan Modular Shoulder SystemCSA-0920-19CSA-0920-192026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569631840Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
03700569631857Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
00885556838211Total Foot System 2Smith & Nephew, Inc.HRS2023-04-18
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00815432024339DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-12-09
00815432024353DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-12-09
00815432024360DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-12-09
00815432024377DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-12-09
00815432024391DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-12-09
00815432024407DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-12-09
00815432024421DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-12-09
00815432024438DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-12-09
00815432024346DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-11-30
00815432024414DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-11-30
00815432024445DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-11-30
00815432024452DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-11-30
00815432024469DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-11-30
00815432024384DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-11-10
00815432025473MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2020-03-20
00815432025480MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2020-03-20
00815432025497MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2020-03-20
00815432025503MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2020-03-20
00815432025510MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2020-03-20
00815432025541MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2020-03-20
00815432025572MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2020-03-20
00815432026524MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2019-03-04
00815432026531MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2019-03-04
00815432026548MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2019-03-04
00815432026555MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2019-03-04
00815432026562MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2019-03-04