FDA.reportPublic FDA data

PERI-LOC

Primary DI
03596010526595
Brand
PERI-LOC
Company
Smith & Nephew, Inc.
Model
71825014
Catalog number
71825014
Device description
3.5MM S-T CORTEX LCKSCREW 14MM
Published
2015-10-05
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
K033669000
K210837000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033669000SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)Smith & Nephew, Inc.2003-12-10HRS
K210837000Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.2021-06-29HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010526595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010526595035960105265953596010526595

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must 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
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
00885556859742Titan Modular Shoulder SystemCSA-0920-20CSA-0920-202026-09-24
00885556859759Titan Modular Shoulder SystemCSA-0920-21CSA-0920-212026-09-24
00885556859766Titan Modular Shoulder SystemCSA-0920-22CSA-0920-222026-09-24
00885556859773Titan Modular Shoulder SystemCSA-0920-23CSA-0920-232026-09-24
00885556859780Titan Modular Shoulder SystemCSA-0920-24CSA-0920-242026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986482501CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482518CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482525CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482532CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482549CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482556CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482563CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482570CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482587CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
03700569602918Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602925Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602932Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602949Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602956Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602963Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602970Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602987Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
00885556819845Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819852Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819869Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819876Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819883Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819890Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819906Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556846599Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-27
00885556910245UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-27
00885556819722Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-26
00885556819746Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-26
00885556819760Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-26
00885556819784UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-26