FDA.reportPublic FDA data

NA

Primary DI
H679394860
Brand
NA
Company
Synthes GmbH
Model
394.86
Catalog number
39486
Device description
LARGE EX-FIX 11MM CRBN FBR ROD 350MM / MR-CONDITIONAL
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
K033158000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033158000SYNTHES REPROCESSED EXTERNAL FIXATION DEVICESSynthes (Usa)2003-11-05KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982199911PrimaryGS10
H679394860SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698219991110886982199911

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system reprocessed componentA component of an external fixation system intended to be used to stabilize a fractured bone/joint. It may be a specially designed frame, clamp, rod, pin, rod-to-rod coupling, rod-to-pin coupling, post, fastener, wire, bolt, washer, nut, hinge, ring, socket, bar, screw, or other device. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

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
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
10705034762852ACIS08.843.805088438052015-09-14
10705034762876ACIS08.843.806088438062015-09-14
10705034762890ACIS08.843.807088438072015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903993241486130° Wise-Lock DHS Plate, 2 Holes, Stainless SteelAuxein Medical Private LimitedKTT2026-04-18
08903993241493130° Wise-Lock DHS Plate, 3 Holes, Stainless SteelAuxein Medical Private LimitedKTT2026-04-18
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
10080196692910MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692927MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692941MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692965MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002065MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002072MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002089MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002096MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002102MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002119MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002126MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002133MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002140MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002157MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
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