FDA.reportPublic FDA data

NA

Primary DI
10705034764009
Brand
NA
Company
Synthes GmbH
Model
241.57
Catalog number
24157
Device description
CERVICAL VERTEBRAE PLATE 20 HOLES/103MM
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K792352000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K792352000SYNTHES CERVICAL VERTABRAE PLATESDePuy Synthes1979-12-06KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034764009PrimaryGS10
H981241570SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503476400910705034764009

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

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
10886982362179NASD03.043.006SD030430062026-07-24
10887587078557NASD03.503.067SD035030672026-07-24
10887587078564NASD03.503.072SD035030722026-07-24
10705034712307NA03.604.002036040022016-12-31
10705034712802NA03.606.011036060112016-12-31
10705034714592NA03.613.012036130122016-12-31
10705034767819VentroFix304.8343048342016-12-31
10705034768939NA314.0643140642016-12-31
10705034768960Click'X314.0673140672016-12-31
10705034768977Click'X314.0683140682016-12-31
10705034768984Click'X314.0693140692016-12-31
10705034769646NA328.0263280262016-12-31
10705034772608NA388.3643883642016-12-31
10705034775401NA389.2883892882016-12-31
10705034777375NA394.5853945852016-12-31
20705034764051NA292.0202920202019-08-29
00863176000317FIBULINKFGS-1100FGS11002020-03-26
00863176000324FIBULINKFGS-1300FGS13002020-03-26
00863176000300FIBULINKFGS-1000FGS10002017-06-08
10886982113078NA04.130.260S04130260S2016-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857598164Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598256Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598263Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598270Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598287Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598294Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598300Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598317Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598324Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598331Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598348Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598355Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598362Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598379Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598386Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598393Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598409Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598416Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598423Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598430Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598447Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598454Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24