FDA.reportPublic FDA data

NA

Primary DI
10705034793146
Brand
NA
Company
Synthes GmbH
Model
499.249
Catalog number
499249
Device description
8.0MM TI DUAL-OPENING SCREW 75MM THRD LENGTH F/6.0MM RODS
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
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034793146PrimaryGS10
H9814992490SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503479314610705034793146

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

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
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14
10705034762852ACIS08.843.805088438052015-09-14
10705034762876ACIS08.843.806088438062015-09-14
10705034762890ACIS08.843.807088438072015-09-14
10705034762913ACIS08.843.808088438082015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536216710neon3Ulrich GmbH & Co. KGKWP2026-05-26
00763000817305VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-03-16
00763000817312VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-03-16
03662663086233LineSiderHighridge Medical, LLCKWP2025-10-03
03662663091046LineSiderHighridge Medical, LLCKWP2025-10-03
03662663091084LineSiderHighridge Medical, LLCKWP2025-10-03
03662663091091LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097345LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097352LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097369LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097376LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097383LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097390LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097406LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097413LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097420LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097437LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097444LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097451LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097468LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097475LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097482LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097499LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097505LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097512LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097529LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097536LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097543LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097550LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097567LineSiderHighridge Medical, LLCKWP2025-10-03