INTRAFIX 254800

GUDID 10886705026715

INTRAFIX Advance Tibial Fastener System BIOCRYL RAPIDE Sheath and Screw Small 7 x 23 mm BR

Medos International Sàrl

Tendon/ligament bone anchor, bioabsorbable
Primary Device ID10886705026715
NIH Device Record Key03a8e14d-316c-495c-8fc9-c1d48ef5dea3
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTRAFIX
Version Model Number254800
Catalog Number254800
Company DUNS482661753
Company NameMedos International Sàrl
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110886705026715 [Primary]

FDA Product Code

MAIFastener, fixation, biodegradable, soft tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2026-03-31
Device Publish Date2017-01-18

On-Brand Devices [INTRAFIX]

10886705026364INTRAFIX Advance Extra Large Trial 25-40mm Plus or Minus 1 Percent
10886705026357INTRAFIX Advance Extra Large Sheath Inserter 30mm
10886705026340INTRAFIX Advance Small Trial 25-40mm Plus or Minus 1 Percent
10886705026333INTRAFIX Advance Small Sheath Inserter 30mm
10886705026326INTRAFIX Advance Large Trial 25-40mm Plus or Minus 1 Percent
10886705026319INTRAFIX Advance Large Sheath Inserter 30mm
10886705026302INTRAFIX Advance Large Sheath Inserter 23mm
10886705026289INTRAFIX Advance Small Sheath Inserter 23mm
10886705027682INTRAFIX Advance Instrumentation Tray 2
10886705027644INTRAFIX Advance Instrumentation Tray 1
10886705027637INTRAFIX Advance Sterilization Case
10886705026753INTRAFIX Advance Tibial Fastener System BIOCRYL RAPIDE Sheath and Screw Large 9 x 30mm BR
10886705026746INTRAFIX Advance Tibial Fastener System BIOCRYL RAPIDE Sheath and Screw Large 9 x 23mm BR
10886705026739INTRAFIX Advance Tibial Fastener System BIOCRYL RAPIDE Sheath and Screw Small 8 x 30mm BR
10886705026722INTRAFIX Advance Tibial Fastener System BIOCRYL RAPIDE Sheath and Screw Small 7 x 30mm BR
10886705026715INTRAFIX Advance Tibial Fastener System BIOCRYL RAPIDE Sheath and Screw Small 7 x 23 mm BR
10886705026685INTRAFIX Advance Tibial Fastener System BIOCRYL RAPIDE Sheath and Screw Large 10 x 30mm BR
10886705026678INTRAFIX Advance Tibial Fastener System BIOCRYL RAPIDE Sheath and Screw Large 10 x 23mm BR
10886705026661INTRAFIX Advance Tibial Fastener System BIOCRYL RAPIDE Sheath and Screw Small 8 x 23mm BR

Trademark Results [INTRAFIX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTRAFIX
INTRAFIX
76629628 3052822 Live/Registered
JOHNSON & JOHNSON
2005-01-27
INTRAFIX
INTRAFIX
74062180 not registered Dead/Abandoned
Orthofix S.R.L.
1990-05-24
INTRAFIX
INTRAFIX
72293928 0877779 Dead/Expired
INTRAVEND A.G.
1968-03-22

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.