FDA.reportPublic FDA data

HOFFMANN

Primary DI
37613327072403
Brand
HOFFMANN
Company
Stryker Trauma SA
Model
4922-1-002
Catalog number
4922-1-002
Device description
Disposable Thumb Wheel
Published
2016-09-24
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

Product Codes#

Code, Name table
CodeName
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122284000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122284000HOFFMANN 3Stryker Corp.2012-10-24KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327072403PackageGS110In Commercial Distribution
07613327072402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332707240337613327072403
07613327072402076133270724027613327072402

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, reusableAn assembly of devices designed to stabilize fractured bones, other than those in the vertebral column, to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, cams, bushings, collars, bolts and nuts; it may also include some instrumentation (e.g., screw drivers, wrenches, drills). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the wrist, elbow, knee, hip and ankle, joint fusions, and limb lengthening. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
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
07613327072631NA3901823901822021-10-27
37613327364102ENDOTRIG1052-61052-62020-09-24
37613327072670VARIAX7038187038182016-09-22
33700586902351AUTOFIX451-0031451-00312015-09-24
33700586903464AUTOFIX451-1136451-11362015-09-24
37613327356503ENDOTRIG106010602018-09-24
37613327362214EDINTRAK406040602017-05-30
37613327072427HOFFMANN4922-1-0034922-1-0032016-09-24
37613327072687HOFFMANN4922-1-0064922-1-0062016-09-24
37613327072694HOFFMANN4922-1-0074922-1-0072016-09-24
37613154639497NA52-0080452-008042018-09-24
37613154639503NA52-0090452-009042018-09-24
37613154639510NA52-0100452-010042018-09-24
37613154639527NA52-0110552-011052018-09-24
37613154639534NA52-0120452-012042018-09-24
37613154639541NA52-0120552-012052018-09-24
37613154639558NA52-0130452-013042018-09-24
37613154639565NA52-0130652-013062018-09-24
37613154639572NA52-0140452-014042018-09-24
37613154639589NA52-0140652-014062018-09-24

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Primary DI, Brand, Company table
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08032909626380ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-17
08051739535730ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-10
08059386747391DOLPHIXCITIEFFE SRLKTT2025-04-02
10080196692729MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692866MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
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10193489002164MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002171MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002188MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002195MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002201MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002218MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002225MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002232MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
08032909624263ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11