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510(k) K921645

AMSEN SPINE IMPACTOR INSTRUMENTS by Advanced Med/Surg, Inc. — Product Code LXH

K921645 is an FDA 510(k) premarket notification submitted by Advanced Med/Surg, Inc. for the device "AMSEN SPINE IMPACTOR INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on June 3, 1992. The device falls under product code LXH (Orthopedic Manual Surgical Instrument), a Class I device regulated under 21 CFR 888.4540. Advanced Med/Surg, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1992
Date Received
April 6, 1992
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 Advanced Med/Surg, Inc.

  • K942108 — COHORT BONE BRUSH (October 11, 1994)
  • K931538 — AMSET(TM) CANNULATED BONE SCREW (May 4, 1994)
  • K921642 — AMSEN DOUBLE-ENDED FORAMINAL PROBE (June 3, 1992)
  • K921644 — AMSEN HOCKEY STICK CHISEL (June 3, 1992)
  • K921643 — AMSEN POSTERIOR DISC EVACUATOR (June 3, 1992)
  • K905023 — AMSET LOCKING PLATE SYSTEM (January 31, 1992)
  • K911768 — AMSET(TM) BONE SCREW (October 4, 1991)
  • K905014 — AMSET PLD SYSTEM (April 1, 1991)
  • K903808 — AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT (January 22, 1991)

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)
  • 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)

FDA data resources