FDA.reportPublic FDA data

CSLP

Primary DI
10705034770710
Brand
CSLP
Company
Synthes GmbH
Model
350.468
Catalog number
350468
Device description
TEMPLATE F/TI CERVICAL SPINE LOCKING PLATE 76MM (68MM)
Published
2016-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819705357Direct MarkingGS10
10705034770710PrimaryGS10
H9813504680SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819705357076118197053577611819705357
1070503477071010705034770710

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10886982077868NA03.311.010033110102015-09-14
10886982077875NA03.311.011033110112015-09-14
10886982077882NA03.311.012033110122015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840286860147Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860154Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860161Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860178Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860185Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860192Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860208Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860215Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860239Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860246Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860253Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860260Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860277Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860284Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860291Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860307Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860314Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860321Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860338Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860345Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860352Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860369Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860376Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860383Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860437Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860451Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860475Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860499Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860512Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860536Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10