FDA.report

Medicon

Primary DI
04046826469986
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
990.11.45
Catalog number
990.11.45
Device description
Plate holding pen
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HWJAWL

Product Code Classifications

CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826469986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826469986040468264699864046826469986

GMDN Terms

TermDefinition
Orthopaedic fixation implant alignment toolA surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+490746220090sales@medicon.de

Regulatory Flags

DUNS number
315492330
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04046826447953Medicon Tray906.91.25906.91.252026-03-24
04046826495923Medicon Tray906.91.86906.91.862026-03-24
04046826495978Medicon Tray906.91.33906.91.332026-03-24
04046826445928Medicon Tray906.91.22906.91.222026-03-20
04046826445935Medicon Tray906.91.23906.91.232026-03-20
04046826447342Medicon Tray906.91.24906.91.242026-03-20
04046826055493Medicon Tray49.97.8249.97.822026-03-19
04046826435400MediExpand Cervical Expandable VBR System 905.80.01905.80.012026-03-19
04046826472061Medicon58.82.2658.82.262026-03-19
04046826472078Medicon58.82.2758.82.272026-03-19
04046826472085Medicon58.82.2858.82.282026-03-19
04046826492632Medicon70.46.2570.46.252026-03-19
04046826492649Medicon70.46.2070.46.202026-03-19
04046826112790Medicon66.54.5066.54.502026-03-04
04046826118327Medicon68.03.5268.03.522026-02-27
04046826118341Medicon68.03.5468.03.542026-02-27
04046826532871Medicon68.83.47A68.83.47A2026-01-19
04046826533427Medicon68.83.44A68.83.44A2026-01-19
04046826055158Medicon Tray49.97.1249.97.122025-12-17
04046826068424Medicon52.70.7152.70.712025-12-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840311262854CONTACT ALPXtant Medical Holdings, Inc.HWJ2026-03-20
06974940306772endophixSuzhou Endophix Co., Ltd.HWJ2026-03-03
06974940306857endophixSuzhou Endophix Co., Ltd.HWJ2026-03-03
06974940306864endophixSuzhou Endophix Co., Ltd.HWJ2026-03-03
06974940306918endophixSuzhou Endophix Co., Ltd.HWJ2026-03-03
00199150066889Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-03-02
00190376709246AMP IIALPHATEC SPINE, INC.HWJ2026-02-18
00860015151322EnFix Instrument Kit - TACTETROUS, INC.HWJ2026-02-11
10886982361288NASynthes GmbHHWJ2026-02-11
00860014213427Awl - Non-CuttingTETROUS, INC.HWJ2026-02-10
00860014213434Cutting Awl - 5.5mmTETROUS, INC.HWJ2026-02-10
00860014213441Cutting Awl - 4.5mmTETROUS, INC.HWJ2026-02-10
00888480489818Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480489825Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480489832Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480597001Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480597018Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480610847Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480610861Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480610878Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00190376680422ProximityALPHATEC SPINE, INC.HWJ2025-12-19
10889981162252Vu a POD™ Prime NanoMetaleneSeaspine Orthopedics CorporationHWJ2025-12-19
10889981162269Vu a POD™ Prime NanoMetaleneSeaspine Orthopedics CorporationHWJ2025-12-19
03662663242929Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663242950Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663243018Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663243117Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663243209Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663243216Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663244725Vital MIS Spinal Fixation SystemHighridge Medical, LLCHWJ2025-12-18