FDA.report

N/A

Primary DI
10705034480169
Brand
N/A
Company
DEPUY SPINE, LLC
Model
698341717
Device description
MODIFIED INSTRUMENT SPREADER 13mm
Published
2023-07-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GADRETRACTOR

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10705034480169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1070503448016910705034480169

GMDN Terms

TermDefinition
Orthopaedic surgical distractor, internalA hand-held manual surgical instrument designed to invasively distract (force apart) two bone surfaces to enable a surgical procedure. It typically aids in fracture reduction by helping to temporarily stabilize bones prior to definitive surgical fixation. It typically consists of a central threaded spindle, a static endpiece and a sliding carriage that can be adjusted using spindle nuts to/from the endpiece to widen or shorten the gap; it facilitates the attachment of orthopaedic bone pins (Schanz screws) screwed into the bones to be distracted. It is typically used for multiple injuries when it is advantageous to perform procedures on a standard operating table. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags

DUNS number
107105876
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10705034579139N/A6983451326983451322026-03-20
10705034579146N/A6983451336983451332026-03-20
10705034579153N/A6983451346983451342026-03-20
10705034579160N/A6983451356983451352026-03-20
10705034189727OCELOT2734009002734009002016-12-31
10705034190945ALIF2735141092735141092016-12-31
10705034192178MOSS2745121002745121002016-12-31
10705034205090KEYSTONE2821804012821804012016-12-31
10705034312286NA6982028036982028032016-11-11
10705034312309NA6982028366982028362016-11-11
10705034316581NA6983276166983276162016-11-11
10705034321400NA6983291776983291772017-02-28
10705034333663NA6983334916983334912017-04-18
10705034371115NA6983353326983353322016-11-11
10705034374543SPOTLIGHT6983366506983366502017-05-18
10705034457123NA6983393746983393742016-11-11
10705034458205NA6983393236983393232016-11-11
10705034459714NA6983389206983389202016-09-14
10705034462677NA6983403376983403372016-11-11
10705034477787NA6983414746983414742016-11-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00198506089763ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089770ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089787ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00841536148008ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-24
00190776418342MillenniumAvalign Technologies, Inc.GAD2026-03-23
00190776418359MillenniumAvalign Technologies, Inc.GAD2026-03-23
00198506089695ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-20
00199150062263Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-03-20
00199150062270Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-03-20
00199150062287Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-03-20
00840277133427Innomed, Inc.INNOMED, INC.GAD2026-03-20
00198506055393ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-19
10885862648587EquinoxeExactech, Inc.GAD2026-03-19
10885862648594EquinoxeExactech, Inc.GAD2026-03-19
10885862661234N/AExactech, Inc.GAD2026-03-19
10885862661371NovationExactech, Inc.GAD2026-03-19
10885862661388NovationExactech, Inc.GAD2026-03-19
10885862661395NovationExactech, Inc.GAD2026-03-19
10885862661401NovationExactech, Inc.GAD2026-03-19
00198506089671ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-17
00198506089688ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-17
00810123209996Adler Instrument CompanyAdler, Inc.GAD2026-03-17
00810220800027Adler Instrument CompanyAdler, Inc.GAD2026-03-17
20763000284897OctoBase™MEDTRONIC, INC.GAD2026-03-14
00841536147766ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-13
00841536147773ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-13
00841536147780ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-13
00810158219298PRINCETONPrinceton Medical Group, Inc.GAD2026-03-12
00810158219342PRINCETONPrinceton Medical Group, Inc.GAD2026-03-12
M93074301120S0Life InstrumentsLife Instrument CorporationGAD2026-03-12