FDA.reportPublic FDA data

DCS

Primary DI
H679281940S0
Brand
DCS
Company
Synthes GmbH
Model
281.940S
Catalog number
281940S
Device description
95 DEG DCS® PLATE 16 HOLES 274MM-STERILE
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPLATE, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K791619000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K791619000DYNAMIC HIP SCREWSynthes (Usa)1979-08-28KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982178053PrimaryGS10
H679281940S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698217805310886982178053

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, sterileA sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

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
true
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
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
08809986482600CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482617CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482624CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482631CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482648CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482655CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482662CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482679CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482686CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482792CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482808CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482877CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482884CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482891CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482907CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482914CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482921CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482938CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482945CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482952CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482969CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482976CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482983CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482990CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986483027CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986483034CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986483041CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482594CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-23
00810112599275TriLEAPSynthes GmbHHRS2025-03-20
00810112599169TriLEAPSynthes GmbHHRS2025-03-18