HEALIX ADVANCE 222425

GUDID 10886705030606

HEALIX ADVANCE SP PEEK ANCHOR 5.5mm

Medos International Sàrl

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID10886705030606
NIH Device Record Key581cd7b1-0946-417c-9819-04a435bb30fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEALIX ADVANCE
Version Model Number222425
Catalog Number222425
Company DUNS482661753
Company NameMedos International Sàrl
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110886705030606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, fixation, nondegradable, soft tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-02
Device Publish Date2019-03-25

On-Brand Devices [HEALIX ADVANCE]

10886705030606HEALIX ADVANCE SP PEEK ANCHOR 5.5mm
10886705030583HEALIX ADVANCE SP PEEK ANCHOR 4.9mm
10886705030354HEALIX ADVANCE KNOTLESS PEEK ANCHOR PEEK Anchor 6.5mm
10886705030347HEALIX ADVANCE KNOTLESS PEEK ANCHOR PEEK Anchor 5.5mm
10886705030330HEALIX ADVANCE KNOTLESS PEEK ANCHOR PEEK Anchor 4.75mm
10886705030590HEALIX ADVANCE SP BIOCOMPOSITE ANCHOR TCP/PLLA Absorbable Anchor 5.5mm
10886705030576HEALIX ADVANCE SP BIOCOMPOSITE ANCHOR TCP/PLLA Absorbable Anchor 4.9mm
10886705030620HEALIX ADVANCE SP BIOCOMPOSITE ANCHOR TCP/PLLA Absorbable Anchor 6.5mm
10886705030613HEALIX ADVANCE SP PEEK ANCHOR 6.5mm
10886705027781HEALIX ADVANCE ANCHOR OPEN HARD BONE KIT Open Instrumentation Kit for 4.5mm and 4.75 HEALIX ADVA

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