FDA.reportPublic FDA data

NA

Primary DI
10705034706962
Brand
NA
Company
Synthes GmbH
Model
SD388.474
Catalog number
SD388474
Device description
LOCK CRIMPER 45 DEG
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
HXQCRIMPER, PIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXQCrimper, PinOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034706962PrimaryGS10
H981SD3884740SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503470696210705034706962

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic wire crimperA hand-held manual surgical instrument designed like wire-closing forceps and used to bend wire or cerclage. 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
10887587060743ChronOS710.000.98S71000098S2015-09-14
10887587060774ChronOS710.003.98S71000398S2015-09-14
10887587060781ChronOS710.011.98S71001198S2015-09-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840124521872PolyLock MidfootFUSION ORTHOPEDICS, LLCHXQ2025-10-02
00841823100375Leadwire Connection CrimperAd-Tech Medical Instrument CorporationHXQ2023-08-31
04026575295371Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHXQ2023-01-11
04026575295388Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHXQ2023-01-11
04026575431557LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2023-01-11
04026575431564LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2023-01-11
04026575431588LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2023-01-11
04026575431595LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2023-01-11
04026575438204LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2023-01-11
04026575031047LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2023-01-11
04026575341474LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-20
04026575317967LINK Instruments - Alignment and positioning instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-16
04026575216703SPARK - InstrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-15
04026575216710SPARK - InstrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-15
04026575216727SPARK - InstrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-15
04026575216734SPARK - InstrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-15
04026575216758TrabecuLink Femoral and Tibial Cone - InstrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-15
04026575216765TrabecuLink Femoral and Tibial Cone - InstrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-15
04026575216772TrabecuLink Femoral and Tibial Cone - InstrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-15
04026575157679LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-14
04026575431571LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-14
04026575436811LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-14
04026575436828LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-14
04026575436835LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2022-12-14
00613994808264Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXQ2022-11-27
00673978047768Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXQ2022-11-26
08800017278148LOSPA IS Spinal SystemCorentec Co., LtdHXQ2022-10-21
08800017278155LOSPA IS Spinal SystemCorentec Co., LtdHXQ2022-10-21
08800017278162LOSPA IS Spinal SystemCorentec Co., LtdHXQ2022-10-21
08800017278179LOSPA IS Spinal SystemCorentec Co., LtdHXQ2022-10-21