HXS — Twister, Wire Class I

FDA Device Classification

FDA product code HXS covers "Twister, Wire", a Class I medical device regulated under 21 CFR 888.4540. Submissions are reviewed by the Orthopedic panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HXS
Device Class
Class I
Regulation Number
888.4540
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K833726bionic instrumentKLEIN WIRE TIGHTENER/BIONIC WIREDecember 22, 1983
K781451orthopedic equipment coFLAT WRENCHSeptember 27, 1978