FDA-Device2018-06-27Class II
P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.
Paragon 28, Inc.
Hazard
Missing drill guide as stated in the package.
Sold states
Worldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, and WI; to countries of: Australia and South Africa.
Affected count
1,626
Manufactured in
4B Inverness Ct E Ste 280, N/A, Englewood, CO, United States
Products
P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2261-2018Don't want to check this manually?
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