FDA.reportPublic FDA data

HOFFMANN

Primary DI
04546540389916
Brand
HOFFMANN
Company
Stryker GmbH
Model
5079-6-050
Catalog number
5079-6-050
Device description
Connecting Rod Micro
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
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
K033476000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033476000MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEMHowmedica Osteonics Corp.2004-01-20KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540389916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540389916045465403899164546540389916

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length50Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
Device count
1
DM exempt
true
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
07613327616859HOFFMANN LRFStryker GmbHKTT2026-07-23
07613327616880HOFFMANN LRFStryker GmbHKTT2026-07-23
07613327616835HOFFMANN LRFStryker GmbHKTT2026-07-21
07613327616866HOFFMANN LRFStryker GmbHKTT2026-07-21
00889795154620Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154637Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154644Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154651Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
10888867544571Arthrex®ARTHREX, INC.KTT2026-03-13
10886982346872MAXFRAMESynthes GmbHKTT2025-01-29
10886982338778MAXFRAMESYNTHES (U.S.A.) LPKTT2024-02-05
10886982343710MAXFRAMESynthes GmbHKTT2024-01-04
10886982343727MAXFRAMESynthes GmbHKTT2024-01-04
10886982343734MAXFRAMESynthes GmbHKTT2024-01-04
10886982338570MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338587MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338594MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338600MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
00841132142325eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132142905eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132142950eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132143025eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
07613327079241HOFFMANNStryker GmbHKTT2018-09-24
07613327079272HOFFMANNStryker GmbHKTT2018-09-24
07613327079333HOFFMANNStryker GmbHKTT2018-09-24
07613327079395HOFFMANNStryker GmbHKTT2018-09-24
07613327079401HOFFMANNStryker GmbHKTT2018-09-24
07613327079449HOFFMANNStryker GmbHKTT2018-09-24
07613327079470HOFFMANNStryker GmbHKTT2018-09-24
07613327079500HOFFMANNStryker GmbHKTT2018-09-24