FDA.report

Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors

Primary DI
07899258656274
Brand
Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
Mini HTA
Catalog number
315-27-01-20
Device description
MINI HTA Ø2,7 x 7,0mm Suture #2-0 Needle 3/8 Circle - 17,9mm
Published
2024-01-11
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
K223114000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K223114000Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGm Dos Reis Industria E Comerico Ltda.2023-08-02MBI

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07899258656274PrimaryGS10

GMDN Terms

TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This 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

Regulatory Flags

DUNS number
900865213
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
true
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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