NA

Primary DI: 10886982307095
Brand: NA
Company: Synthes GmbH
Model: 42.231.295TS
Catalog number: 42231295TS
Device description: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/95MM/STER
Published: 2025-01-31
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
10886982307095	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifier	GTIN-14 normalized
10886982307095	10886982307095

GMDN Terms#

Term, Definition table
Term	Definition
Orthopaedic bone screw (non-sliding)	A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

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
10886982198266	NA	391.73	39173	2016-12-31
10886982312259	NA	60.133.200	60133200	2022-04-12
10886982312266	NA	60.133.300	60133300	2022-06-17
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

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#