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510(k) K841470

REESE OSTEOTOMY GUIDE SYS by Osteotomy Guide Co. — Product Code HTH

K841470 is an FDA 510(k) premarket notification submitted by Osteotomy Guide Co. for the device "REESE OSTEOTOMY GUIDE SYS". The FDA issued a decision of Substantially Equivalent on May 23, 1984. The device falls under product code HTH (Protractor), a Class I device regulated under 21 CFR 888.4600. Osteotomy Guide Co. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1984
Date Received
April 9, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protractor
Device Class
Class I
Regulation Number
888.4600
Review Panel
OR
Submission Type

Other clearances by Osteotomy Guide Co.

  • K861576 — SHORTENING OSTEOTOMY GUIDE (May 12, 1986)
  • K860323 — REESE ARTHRODESIS SCREW (February 19, 1986)

Other clearances for product code HTH

  • K861576 — SHORTENING OSTEOTOMY GUIDE (May 12, 1986)
  • K822305 — ORTHO-LEVEL (August 20, 1982)

FDA data resources