FDA.reportPublic FDA data

NA

Primary DI
10886982075444
Brand
NA
Company
Synthes GmbH
Model
03.130.260
Catalog number
03130260
Device description
PLATE BENDING PLIERS F/1.3MM LCKNG/1.5-2.0MM VAL PLATES-RT
Published
2017-10-12
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
HWWCOUNTERSINK
HXPINSTRUMENT, BENDING OR CONTOURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWWCountersinkOrthopedic1
HXPInstrument, Bending Or ContouringOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819690707Direct MarkingGS10
10886982075444PrimaryGS10
H679031302600SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819690707076118196907077611819690707
1088698207544410886982075444

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. It is typically in the form of pliers, a rod-like (e.g., pin) or bench-top device. 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
10886982228185NA456.456S456456S2015-09-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731146854TITANEX VILEX LLCHWW2026-05-15
00841731146878TITANEX VILEX LLCHWW2026-05-15
00841731146892TITANEX VILEX LLCHWW2026-05-15
00841731146915TITANEX VILEX LLCHWW2026-05-15
00841731146939TITANEX VILEX LLCHWW2026-05-15
03700569620479Newclip InstrumentsNEWCLIP TECHNICSHXP2026-05-07
03700569679170Newclip InstrumentsNEWCLIP TECHNICSHWW2026-05-05
03700569679187Newclip InstrumentsNEWCLIP TECHNICSHWW2026-05-05
00810211043945Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043952Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043969Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043976Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043983Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043990Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211044003Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211044010Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00840311262960Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HXP2026-04-27
08437019739430WasherCap™ Countersink 11 mmABANZA TECNOMED SL.HWW2026-03-30
00810111225281Instrument TrayTreace Medical Concepts, Inc.HWW2026-03-30
00841731135308Redemption VILEX LLCHWW2026-01-12
00840118126250Active CompressionFLOWER ORTHOPEDICS CORPORATIONHWW2025-11-21
00840118126267Active CompressionFLOWER ORTHOPEDICS CORPORATIONHWW2025-11-21
00889795141330Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.HWW2025-11-19
00199150029464Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXP2025-10-19
10888277356269MEDLINEMEDLINE INDUSTRIES, INC.HWW2025-01-29
10888277369238MEDLINEMEDLINE INDUSTRIES, INC.HWW2025-01-29
10886982335784NASynthes GmbHHXP2024-10-09
10886982335913NASynthes GmbHHXP2024-10-09
10886982336293NASynthes GmbHHXP2024-10-09
10886982336309NASynthes GmbHHXP2024-10-09