FDA.reportPublic FDA data

NA

Primary DI
10886982199911
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
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033158000
K082650000
K122455000
K950384000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033158000SYNTHES REPROCESSED EXTERNAL FIXATION DEVICESSynthes (Usa)2003-11-05KTT
K082650000SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONALSynthes (Usa)2008-11-18KTT
K122455000SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEMSynthes2013-04-11KTT
K950384000SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATORSynthes (Usa)1995-05-22LXT

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 noninvasive component, single-useA noninvasive structural component of an external orthopaedic fixation system intended for bone/joint fracture stabilization in conjunction with an invasive bone pin (not included). It is in the form of a full or partial ring, rod (e.g., straight, curved, telescopic), plate, or connector (e.g., screw, bolt, nut, hinge, coupling, fastener); it is not a surgical instrument. This is a single-use device.

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810112599275TriLEAP04.900.251049002512025-03-20
00810112599169TriLEAP04.900.240049002402025-03-18
00810112599763TriLEAP03.900.407039004072025-03-18
00810112599176TriLEAP04.900.241049002412025-03-17
00810112599183TriLEAP04.900.242049002422025-03-17
00810112599190TriLEAP04.900.243049002432025-03-17
00810112599206TriLEAP04.900.244049002442025-03-17
00810112599213TriLEAP04.900.245049002452025-03-17
00810112599220TriLEAP04.900.246049002462025-03-17
00810112599237TriLEAP04.900.247049002472025-03-17
00810112599244TriLEAP04.900.248049002482025-03-17
00810112599251TriLEAP04.900.249049002492025-03-17
00810112599268TriLEAP04.900.250049002502025-03-17
00810112592467TriLeap Lower Etremity Anatomic Plating System60.900.307609003072024-02-23
00810112592528TriLeap Lower Extremity Anatomic Plating03.900.311039003112024-02-23
00810112592566TriLeap Lower Etremity Anatomic Plating System03.900.332039003322024-02-23
00810112597035TriLeap Lower Extremity Plating System04.900.057049000572024-02-21
00810112596793TriLEAP04.900.151049001512026-02-19
00810112597202TriLEAP04.913.035049130352026-02-19
00810112597219TriLEAP04.913.040049130402026-02-19

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
10888867544571Arthrex®ARTHREX, INC.KTT2026-03-13
00810028396166EF1Medshape, Inc.KTT2024-07-09
00810028396159EF1Medshape, Inc.KTT2024-05-31
00810028396173EF1Medshape, Inc.KTT2024-05-31
00810028396142EF1Medshape, Inc.KTT2024-05-31
00885556819791UNI-CP Compression PlateSmith & Nephew, Inc.LXT2023-10-26
00885556839942Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21
00885556839959Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21
00885556839966Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21
00887868549236MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549243MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549250MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549267MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549274MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549281MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549298MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549304MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549311MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549328MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549335MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549342MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549359MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549366MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549373MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549380MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868544699SMOOTH PEGBiomet Orthopedics, LLCLXT2022-09-07