FDA.reportPublic FDA data

NA

Primary DI
10886982070326
Brand
NA
Company
Synthes GmbH
Model
03.037.016
Catalog number
03037016
Device description
BUTTRESS/COMPRESSION NUT
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
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819642423Direct MarkingGS10
10886982070326PrimaryGS10
H679030370160SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819642423076118196424237611819642423
1088698207032610886982070326

GMDN Terms#

Term, Definition table
TermDefinition
Bone-nailing compression screwA rod-like orthopaedic surgical instrument designed to be inserted (screwed) through the insertion handle of an orthopaedic implant aiming arm to impart a force upon a proximally inserted bone nail locking screw thus creating compression on the proximal section of a fractured bone to close the fracture gap with the distal section which can then be locked into final position. It is typically made of high-grade stainless steel and has a threaded portion at the proximal end together with a head for acceptance of a screwdriver or other tool to provide the necessary rotation. It is available in a variety of lengths and is usually used when nailing the tibia or humerus. 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
10887587078540NASD03.501.442SD035014422026-07-29
10886982362179NASD03.043.006SD030430062026-07-24
10887587078557NASD03.503.067SD035030672026-07-24
10887587078564NASD03.503.072SD035030722026-07-24
10705034712307NA03.604.002036040022016-12-31
10705034712802NA03.606.011036060112016-12-31
10705034714592NA03.613.012036130122016-12-31
10705034767819VentroFix304.8343048342016-12-31
10705034768939NA314.0643140642016-12-31
10705034768960Click'X314.0673140672016-12-31
10705034768977Click'X314.0683140682016-12-31
10705034768984Click'X314.0693140692016-12-31
10705034769646NA328.0263280262016-12-31
10705034772608NA388.3643883642016-12-31
10705034775401NA389.2883892882016-12-31
10705034777375NA394.5853945852016-12-31
20705034764051NA292.0202920202019-08-29
00863176000317FIBULINKFGS-1100FGS11002020-03-26
00863176000324FIBULINKFGS-1300FGS13002020-03-26
00863176000300FIBULINKFGS-1000FGS10002017-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376544519InvictusALPHATEC SPINE, INC.LXH2026-07-30
00193082164828ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167416ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167430ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167447ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167454ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167461ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167478ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167492ANTERIS Thoracolumbar Plate SystemSPINECRAFT, LLCLXH2026-07-30
00193082167508ANTERIS Thoracolumbar Plate SystemSPINECRAFT, LLCLXH2026-07-30
00199150081905Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-30
00810166521703X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
00810166523004X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
00810166523011X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
00850041805863X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
04251631412526BEE PLIF CageNGMedical GmbHLXH2026-07-30
07899258632346Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258634647Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653242Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653259Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653266Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653280Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653297Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
09421028110853Tensioner, AP SizerENZTEC LIMITEDLXH2026-07-30
09421028110877Tensioner, BalancerENZTEC LIMITEDLXH2026-07-30
09421028110884Tensioner, DistractorENZTEC LIMITEDLXH2026-07-30
00198506093487ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29
00198506093500ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29
00198506093524ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29
00198506093548ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29