FDA.reportPublic FDA data

KATOR, LLC

Primary DI
B18610305930
Brand
KATOR, LLC
Company
KATOR, LLC
Model
1030593
Catalog number
1030593
Device description
KATOR Suture Anchor, Arthroscopic, 5.0mm x 25mm, 2mm Suture Tape
Published
2016-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152236000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152236000KATOR Suture AnchorKator, LLC2015-11-04MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B18610305930PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ligament bone anchorA non-bioabsorbable device designed to be implanted into bone specifically to attach the ends of a ligament (synthetic or natural source) to the bone, e.g., during reconstructive knee surgery. The device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080346102
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B18610305900KATOR, LLC103059010305902016-08-17
B18610305910KATOR, LLC103059110305912016-08-17
B18610305920KATOR, LLC103059210305922016-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00840277405630Strut SutureRIVERPOINT MEDICAL, LLCMBI2026-03-19
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00840277405722LigaMend™ Soft Button (Blue)RIVERPOINT MEDICAL, LLCMBI2026-03-19
00840277411358No-Tie ButtonRIVERPOINT MEDICAL, LLCMBI2026-03-19
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28437019739748QuadLock™ Fixation System 9mmABANZA TECNOMED SL.MBI2026-01-14
28437019739755QuadLock™ Fixation System 10mmABANZA TECNOMED SL.MBI2026-01-14
28437019739762QuadLock™ Fixation System 11mmABANZA TECNOMED SL.MBI2026-01-14