FDA.reportPublic FDA data

NA

Primary DI
H6794223960
Brand
NA
Company
Synthes GmbH
Model
422.396
Catalog number
422396
Device description
5.0MM TI LOCKING SCREW SELF-DRILLING 75MM
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDSNAIL, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDSNail, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961413000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961413000SYNTHES ANATOMICAL LOCKING PLATE SYSTEMSynthes (Usa)1996-08-07HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982215901PrimaryGS10
H6794223960SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698221590110886982215901

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

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
DM exempt
false
Premarket exempt
false
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
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
08905892004599GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004605GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004612GPCGPC MEDICAL LIMITEDJDS2024-01-31
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08905892004643GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004650GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004667GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004674GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004681GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004698GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004704GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004711GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004728GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004735GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004742GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004759GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004766GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004773GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004780GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004568GPCGPC MEDICAL LIMITEDJDS2023-12-30
08905892004575GPCGPC MEDICAL LIMITEDJDS2023-12-30
08905892006968GPCGPC MEDICAL LIMITEDJDS2023-11-30
08905892006975GPCGPC MEDICAL LIMITEDJDS2023-11-30
08905892006982GPCGPC MEDICAL LIMITEDJDS2023-11-30
08905892006999GPCGPC MEDICAL LIMITEDJDS2023-11-30
08905892007002GPCGPC MEDICAL LIMITEDJDS2023-11-30
08905892007019GPCGPC MEDICAL LIMITEDJDS2023-11-30
08905892007026GPCGPC MEDICAL LIMITEDJDS2023-11-30
08905892007033GPCGPC MEDICAL LIMITEDJDS2023-11-30