NA

Primary DI
H6792416190
Brand
NA
Company
Synthes GmbH
Model
241.619
Catalog number
241619
Device description
LOCKING CALCANEAL PLATE MINI-LEFT
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
LXTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991407000SYNTHES LOCKING CALCANEAL PLATESSynthes (Usa)1999-06-11LXT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982167378PrimaryGS10
H6792416190SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698216737810886982167378

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, sterileA sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

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
08800089416585INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416592INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416608INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416615INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416622INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416639INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416646INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416653INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416660INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416677INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416684INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
10381780065197Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065203Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065210Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065227Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065234Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065241Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065258Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065265Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065272Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065289Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065296Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065302Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065319Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065326Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065333Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065340Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065357Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065364Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065371Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09