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510(k) K844595

ORTHOPEDIC CUSTOM SURGICAL KIT by Xanmed Corp. — Product Code LXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1985
Date Received
November 26, 1984
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 Xanmed Corp.

  • K864623 — OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT (January 14, 1987)
  • K844596 — EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KIT (August 1, 1985)
  • K844593 — CARDIOVASCULAR CUSTOM SURGICAL KIT (June 21, 1985)
  • K844594 — NEURO CUSTOM SURGICAL KIT (June 13, 1985)
  • K851906 — SURGICAL EYE PACK (May 21, 1985)
  • K844597 — MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT (April 8, 1985)
  • K843641 — CATHETER INTRODUCER SYSTEM (October 23, 1984)
  • K843642 — SUBCLAVIAN LEAD INTRODUCER SYS (October 23, 1984)

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  • K001507 — MICROPERFORATION INSTRUMENT (June 14, 2000)
  • K952495 — ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM (January 22, 1996)
  • K943873 — ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY (April 26, 1995)
  • 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)