FDA.reportPublic FDA data

NA

Primary DI
03700569612191
Brand
NA
Company
NEWCLIP TECHNICS
Model
CT3.5L34
Catalog number
CT3.5L34
Published
2017-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152289000Alians Elbow Locking Plating SystemNewclip Technics2016-08-17HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569612191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569612191037005696121913700569612191

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
263281904
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700569621261Newclip InstrumentsANC306ANC3062026-05-11
03700569626181NACT2.8L60CT2.8L602024-11-14
03700569626198NACT2.8L60-STCT2.8L60-ST2024-11-14
03700569627553NACT3.5L38DCT3.5L38D2024-11-14
03700569628154NACT3.5L10D-STCT3.5L10D-ST2024-11-14
03700569628178NACT3.5L12D-STCT3.5L12D-ST2024-11-14
03700569628192NACT3.5L14D-STCT3.5L14D-ST2024-11-14
03700569628215NACT3.5L16D-STCT3.5L16D-ST2024-11-14
03700569628239NACT3.5L18D-STCT3.5L18D-ST2024-11-14
03700569628291NACT3.5L24D-STCT3.5L24D-ST2024-11-14
03700569628314NACT3.5L26D-STCT3.5L26D-ST2024-11-14
03700569644536NACT3.5L10DCT3.5L10D2024-11-14
03700569644543NACT3.5L12DCT3.5L12D2024-11-14
03700569644550NACT3.5L14DCT3.5L14D2024-11-14
03700569644567NACT3.5L16DCT3.5L16D2024-11-14
03700569644574NACT3.5L18DCT3.5L18D2024-11-14
03700569644604NACT3.5L24DCT3.5L24D2024-11-14
03700569647100NACT4.5L30D2024-11-14
03700569647117NACT4.5L30D-STCT4.5L30D-ST2024-11-14
03700569647124NACT4.5L35DCT4.5L35D2024-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731140395ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140401ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140418ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140425ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140432ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140449ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140456ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140463ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140470ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140487ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140494ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140500ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140517ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140524ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140531ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140548ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140555ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140562ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140593ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140609ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140616ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140623ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140630ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140647ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140654ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140661ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140678ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140685ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140692ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140708ARTEMIS FUZEVILEX LLCHWC2026-07-22