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510(k) K925335

ACUFEX INTRA ARTICULAR MEASURING DEVICE by Acufex Microsurgical, Inc. — Product Code HTJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1992
Date Received
October 22, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauge, Depth
Device Class
Class I
Regulation Number
888.4300
Review Panel
OR
Submission Type

Other clearances by Acufex Microsurgical, Inc.

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  • K961853 — PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER (June 21, 1996)
  • K954246 — ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW (February 15, 1996)
  • K952535 — ACUFEX ENDOBUTTON TAPE (February 8, 1996)
  • K953276 — ACUFEX TAG DELIVERY SYSTEM (October 5, 1995)
  • K953459 — ACUFEX TAG ANCHOR (August 23, 1995)
  • K941740 — ACUFEX ROTATOR CUFF FIXATION BUTTON (June 30, 1995)
  • K944500 — ACUFEX PATELLAR BONE BLOCK SIZER (June 12, 1995)
  • K951859 — ACUFEX ENDOBUTTON PACK (June 9, 1995)
  • K946346 — ACUFEX TAG(R) BIOABSORBABLE ANCHORS (April 26, 1995)

Other clearances for product code HTJ

  • K940480 — ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE (March 23, 1994)
  • K873191 — ACROMED INTERBODY DEPTH GAUGES (September 9, 1987)
  • K864426 — RAYLOR(TM) DEPTH GAUGE (November 26, 1986)