FDA.reportPublic FDA data

HOFFMANN

Primary DI
04546540374462
Brand
HOFFMANN
Company
Stryker GmbH
Model
4920-2-080
Catalog number
4920-2-080
Device description
Pelvic Clamp
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K033145000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033145000HOFFMANN II PELVIC CLAMPHowmedica Osteonics Corp.2003-11-05LXT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540374462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540374462045465403744624546540374462

GMDN Terms#

Term, Definition table
TermDefinition
Surgical torque wrench, reusableA hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327616859HOFFMANN LRF4936-0-1304936-0-1302026-07-23
07613327616880HOFFMANN LRF4936-1-3054936-1-3052026-07-23
07613327649109T2, PANGEA5431405431402025-09-25
07613327649130T2, PANGEA5431705431702025-09-25
07613327649253T2, PANGEA6497-1-0606497-1-0602025-09-25
07613327649260T2, PANGEA6497-1-0706497-1-0702025-09-25
07613327649277T2, PANGEA6497-1-070S6497-1-070S2025-09-25
07613327649284T2, PANGEA6497-1-060S6497-1-060S2025-09-25
07613327649291T2, PANGEA6497-1-0806497-1-0802025-09-25
07613327649307T2, PANGEA6497-1-0906497-1-0902025-09-25
07613327649314T2, PANGEA6497-1-080S6497-1-080S2025-09-25
07613327649321T2, PANGEA6497-1-090S6497-1-090S2025-09-25
07613327649338T2, PANGEA6497-1-1006497-1-1002025-09-25
07613327649345T2, PANGEA6497-1-1106497-1-1102025-09-25
07613327649352T2, PANGEA6497-1-100S6497-1-100S2025-09-25
07613327649369T2, PANGEA6497-1-110S6497-1-110S2025-09-25
07613327649376T2, PANGEA6497-1-1306497-1-1302025-09-25
07613327649383T2, PANGEA6497-1-130S6497-1-130S2025-09-25
07613327649390T2, PANGEA6497-1-120S6497-1-120S2025-09-25
07613327649406T2, PANGEA6497-1-1206497-1-1202025-09-25

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