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510(k) K861576

SHORTENING OSTEOTOMY GUIDE by Osteotomy Guide Co. — Product Code HTH

K861576 is an FDA 510(k) premarket notification submitted by Osteotomy Guide Co. for the device "SHORTENING OSTEOTOMY GUIDE". The FDA issued a decision of Substantially Equivalent on May 12, 1986. 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 12, 1986
Date Received
April 28, 1986
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.

  • K860323 — REESE ARTHRODESIS SCREW (February 19, 1986)
  • K841470 — REESE OSTEOTOMY GUIDE SYS (May 23, 1984)

Other clearances for product code HTH

  • K841470 — REESE OSTEOTOMY GUIDE SYS (May 23, 1984)
  • K822305 — ORTHO-LEVEL (August 20, 1982)

FDA data resources