HTH — Protractor Class I

FDA Device Classification

FDA product code HTH covers "Protractor", a Class I medical device regulated under 21 CFR 888.4600. Submissions are reviewed by the Orthopedic panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HTH
Device Class
Class I
Regulation Number
888.4600
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K861576osteotomy guideSHORTENING OSTEOTOMY GUIDEMay 12, 1986
K841470osteotomy guideREESE OSTEOTOMY GUIDE SYSMay 23, 1984
K822305frontier productsORTHO-LEVELAugust 20, 1982