FDA.reportPublic FDA data

LCP

Primary DI
10886982103604
Brand
LCP
Company
Synthes GmbH
Model
04.112.139
Catalog number
04112139
Device description
2.7MM/3.5MM TI LCP LAT DISTAL FIBULA PLATE 4H/LEFT/86MM
Published
2015-09-14
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
HWCScrew, fixation, bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073460000
K083213000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073460000SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATESSynthes (Usa)2008-02-21HRS
K083213000SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATESSynthes (Usa)2008-12-30HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982103604PrimaryGS10
H679041121390SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698210360410886982103604

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982237262NA510.20510202016-12-31
10886982237354NA511.20511202016-12-31
10886982239297NA519.51519512017-02-20
10886982195937NA357.2223572222017-02-20
10886982238115NA511.9045119042016-12-31
10886982239358NA519.53519532016-12-31
10886982249043NA60.550.011605500112017-02-20
10886982249104NA60.550.016605500162017-02-20
10886982249135NA60.550.020605500202017-02-20
10886982249142NA60.550.021605500212017-02-20
10886982254917NA690.5946905942017-02-20
10886982362797NASD03.111.915SD031119152026-08-26
10886982362803NASD03.111.916SD031119162026-08-26
10886982362810NASD03.111.917SD031119172026-08-26
10886982362827NASD03.111.918SD031119182026-08-26
10886982362834NASD03.111.919SD031119192026-08-26
10886982362988NASD312.030SD3120302026-08-26
10886982362995NASD312.031SD3120312026-08-26
10886982363008NASD312.032SD3120322026-08-26
10886982363015NASD312.033SD3120332026-08-26

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
09353903016311NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2026-04-13
09353903016328NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2026-04-13
03700569604233NANEWCLIP TECHNICSHWC2024-11-15
03700569604257NANEWCLIP TECHNICSHWC2024-11-15
03700569604271NANEWCLIP TECHNICSHWC2024-11-15
03700569604295NANEWCLIP TECHNICSHWC2024-11-15
03700569604318NANEWCLIP TECHNICSHWC2024-11-15
03700569604332NANEWCLIP TECHNICSHWC2024-11-15
03700569604356NANEWCLIP TECHNICSHWC2024-11-15
03700569604370NANEWCLIP TECHNICSHWC2024-11-15
03700569633936NANEWCLIP TECHNICSHWC2024-11-15
03700569633950NANEWCLIP TECHNICSHWC2024-11-15
03700569633974NANEWCLIP TECHNICSHWC2024-11-15
03700569633998NANEWCLIP TECHNICSHWC2024-11-15
03700569634018NANEWCLIP TECHNICSHWC2024-11-15
03700569634032NANEWCLIP TECHNICSHWC2024-11-15
03700569634056NANEWCLIP TECHNICSHWC2024-11-15
03700569602918Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602925Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602932Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602949Alians ForearmNEWCLIP TECHNICSHRS2024-11-14