Home / 510(k) Clearances / K911768

510(k) K911768

AMSET(TM) BONE SCREW by Advanced Med/Surg, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1991
Date Received
April 19, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
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)
  • K921643 — AMSEN POSTERIOR DISC EVACUATOR (June 3, 1992)
  • K921644 — AMSEN HOCKEY STICK CHISEL (June 3, 1992)
  • K921645 — AMSEN SPINE IMPACTOR INSTRUMENTS (June 3, 1992)
  • K905023 — AMSET LOCKING PLATE SYSTEM (January 31, 1992)
  • K905014 — AMSET PLD SYSTEM (April 1, 1991)
  • K903808 — AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT (January 22, 1991)

Other clearances for product code HWC

  • K260361 — Treace Medical Concepts (TMC) Screw Fixation System (March 6, 2026)
  • K252901 — Tyber Medical Trauma Screw (December 31, 2025)
  • K251555 — Ultra™ Compression Screw System (November 6, 2025)
  • K252312 — Eleganz IM Threaded Nail System (IM Threaded Nail System) (October 10, 2025)
  • K250536 — MetaFore Small Screw System (October 8, 2025)
  • K252758 — Cannulated Screw and Kirschner (K wire) System (October 2, 2025)
  • K252019 — CurvaFix Low Profile System (August 29, 2025)
  • K251382 — Phoenix Sinus Tarsi Stent System (August 27, 2025)
  • K250867 — Dunamis Screw and Suture Locking System (August 15, 2025)
  • K250251 — Eleganz Fusion Screw System (Fusion Screw System) (June 13, 2025)