FDA.reportPublic FDA data

DCS

Primary DI
10886982003713
Brand
DCS
Company
Synthes GmbH
Model
SD280.990
Catalog number
SD280990
Device description
DHS/DCS COMPRESSION TOOL
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
FZXGuide, surgical, instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982003713PrimaryGS10
H679SD2809900SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698200371310886982003713

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate tensionerA hand-held manual surgical instrument designed to apply tension to an orthopaedic implant (typically a fixation plate) to compress a fracture site prior to final fixation of the implant. It is typically designed with two adjustable legs, one terminating with an anchoring loop that is attached to intact bone and the other terminating with a claw that is attached to the implant which has been fixed to one side of the fracture site; after device placement the fracture is compressed through manual operation of a device mechanism (e.g., turning a central screw). It is typically made of high-grade stainless steel and may be used on simple or compound fractures. 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
10886982342508VOLT02.535.724025357242026-09-25
10886982342515VOLT02.535.726025357262026-09-25
10886982342522VOLT02.535.728025357282026-09-25
10886982342539VOLT02.535.730025357302026-09-25
10886982342546VOLT02.535.732025357322026-09-25
10886982342553VOLT02.535.734025357342026-09-25
10886982342560VOLT02.535.736025357362026-09-25
10886982342577VOLT02.535.738025357382026-09-25
10886982342584VOLT02.535.740025357402026-09-25
10886982342591VOLT02.535.742025357422026-09-25
10886982342607VOLT02.535.744025357442026-09-25
10886982342614VOLT02.535.746025357462026-09-25
10886982342621VOLT02.535.748025357482026-09-25
10886982342638VOLT02.535.750025357502026-09-25
10886982342645VOLT02.535.752025357522026-09-25
10886982342652VOLT02.535.754025357542026-09-25
10886982342669VOLT02.535.756025357562026-09-25
10886982342676VOLT02.535.758025357582026-09-25
10886982342683VOLT02.535.760025357602026-09-25
10886982344878VOLT02.535.765025357652026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06932503563857Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
06932503563864Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
06932503563871Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
00810056993139corraCarlsmed, Inc.FZX2026-01-30
00810112590036MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590043MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590050MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590067MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590098MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590104MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590128MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590135MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590142MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590180MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590197MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590203MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590210MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590227MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590234MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590241MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590258MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590265MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590272MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590289MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590319MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590326MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590333MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590357MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590364MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590371MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05