FDA.reportPublic FDA data

KATOR, LLC

Primary DI
B18610305920
Brand
KATOR, LLC
Company
KATOR, LLC
Model
1030592
Catalog number
1030592
Device description
KATOR Suture Anchor, Arthroscopic, 5.0mm x 25mm, #2 Suture
Published
2016-08-17
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
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
B18610305920PrimaryHIBCC0

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B18610305900KATOR, LLC103059010305902016-08-17
B18610305910KATOR, LLC103059110305912016-08-17
B18610305930KATOR, LLC103059310305932016-08-17

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