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510(k) K943873

ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY by Orthomet, Inc. — Product Code LXH

K943873 is an FDA 510(k) premarket notification submitted by Orthomet, Inc. for the device "ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY". The FDA issued a decision of Substantially Equivalent on April 26, 1995. The device falls under product code LXH (Orthopedic Manual Surgical Instrument), a Class I device regulated under 21 CFR 888.4540. Orthomet, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1995
Date Received
August 9, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Manual Surgical Instrument
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
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)
  • 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)
  • K931678 — ORTHOMET LHMC FEMORAL STEM (October 14, 1994)
  • K925536 — HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM (January 7, 1994)
  • K923243 — PERFECTA TOTAL HIP SYSTEM (January 7, 1994)

Other clearances for product code LXH

  • K192873 — SX-One MicroKnife (December 20, 2019)
  • K140414 — IMBIBE NEEDLE (April 1, 2014)
  • K101609 — SELF RETAINING SOFT TISSUE RETRACTOR (December 9, 2010)
  • K001507 — MICROPERFORATION INSTRUMENT (June 14, 2000)
  • K952495 — ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM (January 22, 1996)
  • K944188 — SPINAL MARKER (April 13, 1995)
  • K941896 — STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR (November 7, 1994)
  • K941711 — HYPERFLEX FLEXIBLE GUIDEWIRES (August 26, 1994)
  • K941605 — STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH (August 5, 1994)
  • K933772 — PUNCH SURGICAL (February 1, 1994)

FDA data resources