FDA.reportPublic FDA data

LCP

Primary DI
10886982187437
Brand
LCP
Company
Synthes GmbH
Model
311.449
Catalog number
311449
Device description
PUSH-PULL REDUCTION DEVICE FOR 4.5MM LCP® PLATES
Published
2016-12-31
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
HTDFORCEPS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819915282Direct MarkingGS10
10886982187437PrimaryGS10
H6793114490SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819915282076118199152827611819915282
1088698218743710886982187437

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone-reduction toolA hand-held manual surgical instrument that is fed down the intramedullary canal of a long bone (e.g., the femur) to help reposition a fracture where the two sections are out of alignment to achieve reduction for consequent reaming and nailing of the bone. It is typically a short cylindrical device with a protruding pointed tip (straight or angled) and which is secured to the distal end of a long, thin, flexible rod/shaft having a handle at the proximal end. It is pressed down the intramedullary canal to the fracture site and the surgeon manipulates the alignment, reducing the bone fragments under image-intensifier control. It is made of high-grade stainless steel. This is a reusable device.

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982312327NA68.134.011681340112026-10-16
10886982346704VOLT68.134.111681341112026-10-16
10886982346735VOLT68.134.200681342002026-10-16
10886982363282NA68.045.017680450172026-10-16
10886982363299NA68.045.018680450182026-10-16
10886982363305NA68.045.019680450192026-10-16
10886982363312NA68.045.020680450202026-10-16
10705034753690ChronOS07.801.100.99S0780110099S2015-09-14
10705034753706ChronOS07.801.101.99S0780110199S2015-09-14
10705034753713ChronOS07.801.110.99S0780111099S2015-09-14
10705034753720ChronOS07.801.111.99S0780111199S2015-09-14
10705034753737ChronOS07.801.200.99S0780120099S2015-09-14
10705034799933ChronOS710.002.99S71000299S2015-09-14
10705034799940ChronOS710.014.99S71001499S2015-09-14
10705034799957ChronOS710.019.99S71001999S2015-09-14
10705034799964ChronOS710.021.99S71002199S2015-09-14
10705034799971ChronOS710.025.99S71002599S2015-09-14
10705034799988ChronOS710.026.99S71002699S2015-09-14
10705034799995ChronOS710.027.99S71002799S2015-09-14
10705034800004ChronOS710.038.99S71003899S2015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435356MillenniumAvalign Technologies, Inc.HTD2026-10-19
00190776435158MillenniumAvalign Technologies, Inc.HTD2026-10-16
00192896123878Allis Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00192896123885Allis Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00192896123892Ceramitec Debakey ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00192896123908Debakey ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00192896123915Ceramitec Debakey ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00190776434717MillenniumAvalign Technologies, Inc.HTD2026-10-12
00190776434748MillenniumAvalign Technologies, Inc.HTD2026-10-12
00190776434755MillenniumAvalign Technologies, Inc.HTD2026-10-12
00190776434243MillenniumAvalign Technologies, Inc.HTD2026-10-09
00190776436490MilleniumAvalign Technologies, Inc.HTD2026-10-08
B382SD9071922050Surgical DirectSurgical Direct, Inc.HTD2026-10-08
B382SD918660100Surgical DirectSurgical Direct, Inc.HTD2026-10-08
B382SD9013551000Surgical DirectSurgical Direct, Inc.HTD2026-10-07
B382SD9013551010Surgical DirectSurgical Direct, Inc.HTD2026-10-07
G1415140730Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-10-07
G1415141510Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-10-07
G141514271180Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-10-07
G141549012180Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-10-07
00192896123793Adson Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
00192896123809Micro Skinner ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
00192896123823Thumb Dressing ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
00192896123830Thumb Dressing ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
00192896123847Thumb Dressing ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
G141510443190Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G141511368200Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G141511368300Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G14151423610Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G14152810910Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30