FDA.report

neon3

Primary DI
04052536216710
Brand
neon3
Company
Ulrich GmbH & Co. KG
Model
CS 3921-01
Device description
Probe, cannulated, for screws Ø 4.5 / 5.5 mm, coupling B
Published
2026-05-26
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
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
NKGOrthosis, cervical pedicle screw spinal fixation

Product Code Classifications

CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions

SubmissionSupplement
K150650000
K161032000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K150650000neon3Ulrich GmbH & Co. KG2015-09-24NKG
K161032000neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG2016-12-22NKG

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04052536085316PreviousGS10
04052536216710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04052536085316040525360853164052536085316
04052536216710040525362167104052536216710

GMDN Terms

TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+4973196540safety@ulrichmedical.com

Regulatory Flags

DUNS number
315494757
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
04052536161775neon3CS 3920-012026-05-26
04052536018772pezoCS 3396-022026-03-17
04052536018819pezoCS 3397-022026-03-17
04052536018192pezoCS 3365-072026-03-16
04052536018208pezoCS 3365-082026-03-16
04052536018215pezoCS 3365-092026-03-16
04052536018222pezoCS 3365-102026-03-16
04052536018239pezoCS 3365-112026-03-16
04052536018246pezoCS 3365-122026-03-16
04052536018253pezoCS 3365-132026-03-16
04052536018260pezoCS 3365-142026-03-16
04052536018277pezoCS 3365-152026-03-16
04052536018314tezoCS 3372-012026-03-16
04052536018321tezoCS 3372-022026-03-16
04052536215522tezoCS 33662026-03-16
04052536215539tezoCS 3370-012026-03-16
04052536215546tezoCS 3370-022026-03-16
04052536215577tezoCS 3374CS 33742026-03-16
04052536017546tezoCS 3340-102026-03-12
04052536017560tezoCS 3341-102026-03-12

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07290117356876CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDNKG2026-03-23
17290117356880CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDNKG2026-03-23
17290117356897CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDNKG2026-03-23
00763000990695INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC MINIMED, INC.NKG2026-03-22
00763000990701INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990718INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990725INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990732INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990749INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990756INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990763INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990770INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990787INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990794INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990800INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990817INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990824INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990831INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990848INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990855INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990862INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990879INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990886INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990893INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990909INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990916INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990923INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990930INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990947INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990954INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22