Home / 510(k) Clearances / K881876

510(k) K881876

DYNAMIC CRUCIATE TESTER by Dyonics, Inc. — Product Code LYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1988
Date Received
May 4, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Arthrometer
Device Class
Class I
Regulation Number
890.1615
Review Panel
NE
Submission Type

Other clearances by Dyonics, Inc.

  • K900070 — MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM (February 16, 1990)
  • K896416 — DYONICS SHOULDER PORTAL SYSTEM (January 2, 1990)
  • K893136 — SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTY (December 14, 1989)
  • K890665 — MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIES (November 3, 1989)
  • K894728 — DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFE (August 18, 1989)
  • K892062 — PS3500 ARTHROSCOPIC SURGICAL SYSTEM (June 23, 1989)
  • K884839 — MODIFIED SAW BLADES TO THE SAGITAL SAW (December 7, 1988)
  • K880739 — DYONICS DRILL GUIDE/ISOMETER SYSTEM (March 21, 1988)
  • K880150 — PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM (March 4, 1988)
  • K870212 — ARTHROSCOPIC SHOULDER HOLDER (February 20, 1987)

Other clearances for product code LYH

  • K943197 — KT1000/S KNEE LIGAMENT ARTHROMETER (March 2, 1995)
  • K942059 — KT2000 KNEE LIGAMENT ARTHROMETER (September 20, 1994)
  • K834462 — GENUCOM (February 9, 1984)
  • K812806 — KT-1000 DEVICE (November 10, 1981)