FDA.reportPublic FDA data

NexGen Anterior Cervical Plate System

Primary DI
00840019937818
Brand
NexGen Anterior Cervical Plate System
Company
PRECISION SPINE, INC.
Model
65-FS-2510
Catalog number
65-FS-2510
Device description
Screw Fixation Pin
Published
2020-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWDStarter, Bone Screw

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWDStarter, Bone ScrewOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019937818PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019937818008400199378188400199378180840019937818

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079398589
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840019904650Slimplicity Anterior Cervical Plate SystemACP118ACP1182019-04-11
00840019904667Slimplicity Anterior Cervical Plate SystemACP120ACP1202019-04-11
00840019904674Slimplicity Anterior Cervical Plate SystemACP122ACP1222019-04-11
00840019904681Slimplicity Anterior Cervical Plate SystemACP124ACP1242019-04-11
00840019904698Slimplicity Anterior Cervical Plate SystemACP126ACP1262019-04-11
00840019904704Slimplicity Anterior Cervical Plate SystemACP128ACP1282019-04-11
00815362021446Slimplicity Anterior Cervical Plate System08-902008-90202019-04-01
00815362021453Slimplicity Anterior Cervical Plate System08-902108-90212019-04-01
00815362021460Slimplicity Anterior Cervical Plate System08-902408-90242019-04-01
00815362021477Slimplicity Anterior Cervical Plate System08-902508-90252019-04-01
00815362021484Slimplicity Anterior Cervical Plate System08-902608-90262019-04-01
00815362021729Slimplicity Anterior Cervical Plate System50-001850-00182019-04-01
00815362021088Slimplicity Anterior Cervical Plate System08-011208-01122019-03-29
00815362021118Slimplicity Anterior Cervical Plate System08-011808-01182019-03-29
00815362021125Slimplicity Anterior Cervical Plate System08-012008-01202019-03-29
00815362021132Slimplicity Anterior Cervical Plate System08-012208-01222019-03-29
00815362021149Slimplicity Anterior Cervical Plate System08-012408-01242019-03-29
00815362021156Slimplicity Anterior Cervical Plate System08-012608-01262019-03-29
00815362021163Slimplicity Anterior Cervical Plate System08-012808-01282019-03-29
00815362021170Slimplicity Anterior Cervical Plate System08-022608-02262019-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731134752Hintermann Series VILEX LLCHWD2025-09-17
00840019968867Dakota ALIF Plate SystemPRECISION SPINE, INC.HWD2025-03-13
00840180529270General InstrumentsALPHATEC SPINE, INC.HWD2024-08-01
B07315K0140200NIDO Pedicle Screw SystemKalitec Direct LLCHWD2023-10-06
B07315K0160200NIDO Pedicle Screw SystemKalitec Direct LLCHWD2023-10-06
00887868570940Distal Screw SheathBiomet Orthopedics, LLCHWD2023-08-15
00887868570049Distal ScrewBiomet Orthopedics, LLCHWD2023-06-13
00887868570124Lag Screw TrocharBiomet Orthopedics, LLCHWD2023-06-13
00887868570148Affixus®Biomet Orthopedics, LLCHWD2023-06-13
00887868570155Anti-Rotation Screw SheathBiomet Orthopedics, LLCHWD2023-06-13
00887868570162Anti-Rotation Screw TrocharBiomet Orthopedics, LLCHWD2023-06-13
00887868570179Anti-Rotation Screw SleeveBiomet Orthopedics, LLCHWD2023-06-13
00887868570186Lag Screw SheathBiomet Orthopedics, LLCHWD2023-06-13
00887868570193Lag Screw SleeveBiomet Orthopedics, LLCHWD2023-06-13
00887868570230Lag Screw TapBiomet Orthopedics, LLCHWD2023-06-13
00887868570247Distal Screw TrocharBiomet Orthopedics, LLCHWD2023-06-13
00844856069756ArsenalALPHATEC SPINE, INC.HWD2023-05-13
00190376477954AMP-LTXALPHATEC SPINE, INC.HWD2023-04-27
00190376477961AMP-LTXALPHATEC SPINE, INC.HWD2023-04-27
00190376477978AMP-LTXALPHATEC SPINE, INC.HWD2023-04-27
00190376477985AMP-LTXALPHATEC SPINE, INC.HWD2023-04-27
00885556864869Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
00885556864876Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
00885556864883Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
00885556864890Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
00885556864906Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
04026575182572LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHWD2022-12-27
04026575046768Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWD2022-12-20
04026575395521SPARK - InstrumentsWALDEMAR LINK GmbH & Co. KGHWD2022-12-16
04026575347698LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHWD2022-12-15