FDA.reportPublic FDA data

N/A

Primary DI
04052536085347
Brand
N/A
Company
Ulrich GmbH & Co. KG
Model
CS 3923-01
Catalog number
CS 3923-01
Device description
Trocar, cannulated, for trocar drill wire, Ø 1.5 mm
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
NKGOrthosis, cervical pedicle screw spinal fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150650000
K161032000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04052536085347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052536085347040525360853474052536085347

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4907319654152safety@ulrichmedical.com
+4973196540safety@ulrichmedical.com

Regulatory Flags#

DUNS number
315494757
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04052536085330neon3CS 3922-4102026-05-28
04052536085361neon3CS 3924-4102026-05-28
04052536085491neon3CS 39302026-05-28
04052536085507neon3CS 39312026-05-28
04052536085552neon3CS 39342026-05-28
04052536161836neon3CS 3926-032026-05-28
04052536161867neon3CS 3927-032026-05-28
04052536161959neon3CS 3936-012026-05-28
04052536161966neon3CS 3937-032026-05-28
04052536161973neon3CS 3937-042026-05-28
04052536161775neon3CS 3920-012026-05-26
04052536216710neon3CS 3921-012026-05-26
04052536085323N/ACS 3921-02CS 3921-022016-09-22
04052536085354N/ACS 3923-02CS 3923-022016-09-22
04052536085460N/ACS 3929-02CS 3929-022016-09-22
04052536085484N/ACS 3929-04CS 3929-042016-09-22
04052536085521N/ACS 3932-02CS 3932-022016-09-22
04052536085545N/ACS 3933CS 39332016-09-22
04052536161782neon³ CT spinal stabilizationCS 3925-01CS 3925-012016-09-22
04052536161799neon³ CT spinal stabilizationCS 3925-02CS 3925-022016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536085491neon3Ulrich GmbH & Co. KGNKG2026-05-28
04052536085491neon3Ulrich GmbH & Co. KGKWP2026-05-28
07613153143734XIA STAINLESS STEELStryker CorporationKWP2015-09-14
07613153143741XIA STAINLESS STEELStryker CorporationKWP2015-09-14
07613154111725OASYSStryker CorporationKWP2015-09-14
07613154129867OASYSStryker CorporationKWP2015-09-14
07613154129874OASYSStryker CorporationNKG2015-09-14
07613154170135OASYSStryker CorporationNKG2015-09-14
07613154170142OASYSStryker CorporationKWP2015-09-14
07613154170159OASYSStryker CorporationNKG2015-09-14
07613154170166OASYSStryker CorporationKWP2015-09-14
07613154253883OASYSStryker CorporationNKG2015-09-14
07613154345014MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345021MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345038MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345045MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345052MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345069MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345090MAC TITANIUMStryker CorporationKWP2015-09-14
07613154408085OASYSStryker CorporationNKG2015-09-14
07613153045670XIA IStryker CorporationKWP2014-12-08
07613153045700XIA IStryker CorporationKWP2014-12-08
07613153045717XIA IStryker CorporationKWP2014-12-08
07613153045724XIA IStryker CorporationKWP2014-12-08
07613153045731XIA IStryker CorporationKWP2014-12-08
07613153045755XIA IStryker CorporationKWP2014-12-08
07613153045762XIA IIStryker CorporationKWP2014-12-08
07613153045793XIA IIStryker CorporationKWP2014-12-08
07613153045847XIA IIStryker CorporationKWP2014-12-08
07613153045854XIA IIStryker CorporationKWP2014-12-08