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510(k) K931678

ORTHOMET LHMC FEMORAL STEM by Orthomet, Inc. — Product Code HMC

K931678 is an FDA 510(k) premarket notification submitted by Orthomet, Inc. for the device "ORTHOMET LHMC FEMORAL STEM". The FDA issued a decision of Substantially Equivalent on October 14, 1994. The device falls under product code HMC (Monitor, Eye Movement, Diagnostic), a Class II device regulated under 21 CFR 886.1510. Orthomet, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1994
Date Received
April 6, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Eye Movement, Diagnostic
Device Class
Class II
Regulation Number
886.1510
Review Panel
OP
Submission Type

Other clearances by Orthomet, Inc.

  • K936310 — ORTHOMET HMC FEMORAL STEM COMPONENT (June 7, 1995)
  • K945783 — ORTHOMET TITANIUM HYBRID FEMORAL STEM (May 30, 1995)
  • K943873 — ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY (April 26, 1995)
  • K944752 — ORTHOMET RESURFACING FEMORAL COMPONENT (December 28, 1994)
  • K930771 — PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM (November 30, 1994)
  • K926334 — AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER (October 18, 1994)
  • K932677 — AXIOM TOTAL KNEE SYSTEM (October 14, 1994)
  • K931333 — ORTHOMET ACETABULAR CUP SYSTEM (October 14, 1994)
  • K925536 — HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM (January 7, 1994)
  • K923243 — PERFECTA TOTAL HIP SYSTEM (January 7, 1994)

FDA data resources