FDA.report

MectaLock Ti Triple Loaded Suture Anchor

Primary DI
07630345788009
Brand
MectaLock Ti Triple Loaded Suture Anchor
Company
Medacta International SA
Model
05.10.021
Device description
MectaLock TI - Ø5.0 - 3x USP#2
Published
2023-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications

CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions

SubmissionSupplement
K223582000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K223582000MectaLock TI Triple Loaded Suture AnchorMedacta International S.A.2023-02-24MBI

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630345788009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07630345788009076303457880097630345788009

GMDN Terms

TermDefinition
Soft-tissue/mesh anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials/implants (e.g., mesh, sutures); it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is typically a threaded screw-like device, and is made of a material that cannot be chemically degraded or absorbed via natural body processes (e.g., metal, polypropylene); it is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized disposable applicator which may be included.

Sterilization Methods

Method

Regulatory Flags

DUNS number
488227125
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

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