FDA.reportPublic FDA data

NexGen Anterior Cervical Plate System

Primary DI
00840019937849
Brand
NexGen Anterior Cervical Plate System
Company
PRECISION SPINE, INC.
Model
65-IN-0015
Catalog number
65-IN-0015
Device description
Fixed Awl - Large Handle
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
HWJAwl

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019937849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019937849008400199378498400199378490840019937849

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
00857915007767IM Nail AwlA.M. SURGICAL, INC.HWJ2026-06-10
00840311245376Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HWJ2026-04-30
08800322758137Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWJ2026-04-21
00860015151308EnFix Instrument Kit - CompleteTETROUS, INC.HWJ2026-02-24
00887868287473Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCHWJ2025-11-12
03662663108126Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCHWJ2025-11-12
03662663109949InViZia Anterior Cervical Plate SystemHighridge Medical, LLCHWJ2025-11-12
03662663128759PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCHWJ2025-11-12
03662663129015Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHWJ2025-11-12
07640375234773SCARLET AL-T INSTRUMENTATIONSpineArt SAHWJ2025-11-10
08059386744338Orthopaedic Surgical InstrumentsCITIEFFE SRLHWJ2025-11-06
00763000674410n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-26
09120129291507Awl, Curved, CannulatedI.T.S. GmbHHWJ2025-10-21
09120129291514Awl TrocarI.T.S. GmbHHWJ2025-10-21
00763000878245n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-20
00840180541050General InstrumentsALPHATEC SPINE, INC.HWJ2025-10-17
00763000885243n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-11
00816342025522AWLPARCUS MEDICAL LLCHWJ2025-09-16
00841732142329GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2025-03-31
00841732142336GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2025-03-31
00841732151642GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2025-03-31
00841732151734GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2025-03-31
00841732160330GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2025-03-31
08800104099977Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HWJ2025-03-17
00841732166745GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2024-12-04
00841732134393GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732134409GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732134416GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732134423GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732135406GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07