# OSSAWARE BIOTECH CO., LTD.

FEI: 3013340866
Status: Active
Establishment types: Manufacture Medical Device
Owner/operator: OSSAWARE BIOTECH CO., LTD. (#10075919)

Address: No. 51, Xinggong Rd.,, Shenkang Hsiang Changhua, 50971, TW

Mandatory US Agent: Cusmed Biotech LLC

## Products

Total registered: 1
Top product codes: GXR
Regulation §: 882.5250

Proprietary names: 99050139S CirFIX Burr Hole Cover, Radiolucent Revisable Type+Screwdriver, PEEK, 13mm/9mm, Sterile, 9901001.15S connectCMF Flap Fixator, Anti-loose Type+Screwdriver, PEEK, D15mm, Sterile, 9900102.20S connectCMF Flap Fixator, Replaceable Type+Screwdriver, PEEK, D20mm, Sterile, 9905014.11S CirFIX Burr Hole Cover, Radiolucent Revisable Type+Screwdriver, PEEK, 14mm/11mm, Sterile, 9906014.11S CirFIX Burr Hole Cover, Radiolucent Revisable Type+Screwdriver for Shunt & ICP, PEEK, 14mm/11mm, Sterile, 9900001.15S connectCMF Flap Fixator, Replaceable Type+Screwdriver, PEEK, D15mm, Sterile, 9904104.22S connectCMF Flap Fixator, Low Profile Anti-loose Type+Screwdriver, PEEK, D22mm, Sterile, 99050118S CirFIX Burr Hole Cover, Radiolucent Revisable Type+Screwdriver, PEEK, 11mm/8mm, Sterile, 9903101.15S connectCMF Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D15mm, Sterile, 9904002.20S connectCMF Flap Fixator, Low Profile Anti-loose Type+Screwdriver, PEEK, D20mm, Sterile

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223013340866%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3013340866