FDA.reportPublic FDA data

NA

Primary DI
10886982275486
Brand
NA
Company
Synthes GmbH
Model
412.221S
Catalog number
412221S
Device description
5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 60MM-STERILE
Published
2018-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
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
K000682000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000682000SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEMSynthes (Usa)2000-05-01KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982275486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698227548610886982275486

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

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
Expiration date on label
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
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
00810028396166EF1Medshape, Inc.KTT2024-07-09
00810028396159EF1Medshape, Inc.KTT2024-05-31
00810028396173EF1Medshape, Inc.KTT2024-05-31
00810028396142EF1Medshape, Inc.KTT2024-05-31
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