NA

Primary DI: 10886982307019
Brand: NA
Company: Synthes GmbH
Model: 42.231.255TS
Catalog number: 42231255TS
Device description: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/55MM/STER
Published: 2021-04-01
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#

xx.xx

Product Codes#

Code, Name table
Code	Name
JDQ	Cerclage, fixation

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
JDQ	Cerclage, Fixation	Orthopedic	2

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
K162124	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K162124	000	Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins	DePuy Synthes	2017-03-29	JDP

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
10886982307019	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifier	GTIN-14 normalized
10886982307019	10886982307019

GMDN Terms#

Term, Definition table
Term	Definition
Orthopaedic bone screw, non-bioabsorbable, sterile	A small, 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). There are a number of kinds available: 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 across bone fragments.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
Phone	Email
+1(800)255-2500	xx@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 DI	Brand	Model	Catalog	Published
10887587060743	ChronOS	710.000.98S	71000098S	2015-09-14
10887587060774	ChronOS	710.003.98S	71000398S	2015-09-14
10887587060781	ChronOS	710.011.98S	71001198S	2015-09-14
10886982228185	NA	456.456S	456456S	2015-09-14
10705034717081	Zero-P	03.617.792	03617792	2015-09-14
10705034717098	Zero-P	03.617.795	03617795	2015-09-14
10705034717203	NA	03.617.907	03617907	2015-09-14
10705034722634	NA	03.804.512S	03804512S	2019-08-10
10705034731841	NA	03.820.159S	03820159S	2019-08-10
10705034736075	USS	04.607.038	04607038	2015-09-14
10705034742199	Zero-P	04.617.232S	04617232S	2015-09-14
10705034754444	OPAL	08.803.114	08803114	2015-09-14
10705034754468	OPAL	08.803.116	08803116	2015-09-14
10705034754529	OPAL	08.803.134	08803134	2015-09-14
10705034754611	OPAL	08.803.214	08803214	2015-09-14
10705034754635	OPAL	08.803.216	08803216	2015-09-14
10705034754697	OPAL	08.803.234	08803234	2015-09-14
10705034754741	VERTEBRAL SPACER-TR	08.804.037	08804037	2015-09-14
10705034754765	VERTEBRAL SPACER-TR	08.804.039	08804039	2015-09-14
10705034754826	VERTEBRAL SPACER-TR	08.804.047	08804047	2015-09-14

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
07899258607887	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258607900	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258654850	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258654867	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258654874	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258654881	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258654898	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258654904	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258654911	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258654928	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258654935	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258654942	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258654959	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258654966	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258654973	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258654980	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258654997	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258655017	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258655024	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258655338	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258657714	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258657721	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258657738	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258657745	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258657752	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258657776	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258657790	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258657813	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258657820	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17
07899258657837	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDQ	2024-01-17

NA

Related Records#

Contact Domains#

Product Codes#

Product Code Classifications#

Premarket Submissions#

Premarket Details#

Identifiers And Packaging#

Alternate GTIN / UPC / EAN Codes

GMDN Terms#

Sterilization Methods#

Contacts#

Regulatory Flags#

Other Devices From This Company#

Other Devices Sharing Product Codes#