Home / 510(k) Clearances / K903808

510(k) K903808

AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT by Advanced Med/Surg, Inc. — Product Code IZG

K903808 is an FDA 510(k) premarket notification submitted by Advanced Med/Surg, Inc. for the device "AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT". The FDA issued a decision of Substantially Equivalent on January 22, 1991. The device falls under product code IZG (System, X-Ray, Photofluorographic), a Class II device regulated under 21 CFR 892.1730. Advanced Med/Surg, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1991
Date Received
August 20, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Photofluorographic
Device Class
Class II
Regulation Number
892.1730
Review Panel
RA
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)
  • K921645 — AMSEN SPINE IMPACTOR INSTRUMENTS (June 3, 1992)
  • K921644 — AMSEN HOCKEY STICK CHISEL (June 3, 1992)
  • K921643 — AMSEN POSTERIOR DISC EVACUATOR (June 3, 1992)
  • K921642 — AMSEN DOUBLE-ENDED FORAMINAL PROBE (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)

Other clearances for product code IZG

  • K960082 — DISCOGRAPHY KIT (March 21, 1996)
  • K960146 — G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY (February 27, 1996)
  • K913436 — PXI PNEUMATIC COMPRESSION PADDLE (November 5, 1992)
  • K920393 — MU125M MOBILE X-RAY SYSTEM (April 6, 1992)
  • K910503 — DISCOGRAPHY KIT (October 7, 1991)
  • K892659 — ELECTRODELCA (November 21, 1989)

FDA data resources