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510(k) K921645

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

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.

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  • K931538 — AMSET(TM) CANNULATED BONE SCREW (May 4, 1994)
  • K921643 — AMSEN POSTERIOR DISC EVACUATOR (June 3, 1992)
  • K921642 — AMSEN DOUBLE-ENDED FORAMINAL PROBE (June 3, 1992)
  • K921644 — AMSEN HOCKEY STICK CHISEL (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)

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  • K941711 — HYPERFLEX FLEXIBLE GUIDEWIRES (August 26, 1994)
  • K941605 — STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH (August 5, 1994)