
Tecres S.P.A.
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SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321 is an FDA 510(k)-cleared medical device (K062274) manufactured by Tecres S.P.A.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 21, 2008. Regulation: 8.