FDA.reportPublic FDA data

NA

Primary DI
03700569616328
Brand
NA
Company
NEWCLIP TECHNICS
Model
KIT-AMS
Catalog number
KIT-AMS
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143061000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143061000Activ Ankle Locking Plating SystemNewclip Technics2015-01-26HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569616328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569616328037005696163283700569616328

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other 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 single-use device.

Regulatory Flags#

DUNS number
263281904
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700569602918Alians ForearmETSIS1ETSIS12024-11-14
03700569602925Alians ForearmETSIS1-STETSIS1-ST2024-11-14
03700569602932Alians ForearmETSIS2ETSIS22024-11-14
03700569602949Alians ForearmETSIS2-STETSIS2-ST2024-11-14
03700569602956Alians ForearmETSIS3ETSIS32024-11-14
03700569602963Alians ForearmETSIS3-STETSIS3-ST2024-11-14
03700569602970Alians ForearmETSIS4ETSIS42024-11-14
03700569602987Alians ForearmETSIS4-STETSIS4-ST2024-11-14
03700569604233NAQOT3.5L10-STQOT3.5L10-ST2024-11-15
03700569604257NAQOT3.5L12-STQOT3.5L12-ST2024-11-15
03700569604271NAQOT3.5L14-STQOT3.5L14-ST2024-11-15
03700569604295NAQOT3.5L16-STQOT3.5L16-ST2024-11-15
03700569604318NAQOT3.5L18-STQOT3.5L18-ST2024-11-15
03700569604332NAQOT3.5L20-STQOT3.5L20-ST2024-11-15
03700569604356NAQOT3.5L22-STQOT3.5L22-ST2024-11-15
03700569604370NAQOT3.5L24-STQOT3.5L24-ST2024-11-15
03700569633936NAQBT2.8L18QBT2.8L182024-11-15
03700569633950NAQBT2.8L20QBT2.8L202024-11-15
03700569633974NAQBT2.8L22QBT2.8L222024-11-15
03700569633998NAQBT2.8L24QBT2.8L242024-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842188131615CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131639CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131653CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131677CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131721CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00889095401820ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401820ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401844ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401844ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401868ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401868ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401882ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401882ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401905ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401905ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401929ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401929ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402285ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402285ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402438ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402438ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402483ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402483ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402537ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402537ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411263ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411263ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411287ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411287ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411300ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25