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510(k) K820367

INTRA-ARTICULAR SURGICAL SYSTEM by Dyonics, Inc. — Product Code KIJ

K820367 is an FDA 510(k) premarket notification submitted by Dyonics, Inc. for the device "INTRA-ARTICULAR SURGICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on May 7, 1982. The device falls under product code KIJ (Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Dyonics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1982
Date Received
February 9, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
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)
  • K881876 — DYNAMIC CRUCIATE TESTER (November 17, 1988)
  • K880739 — DYONICS DRILL GUIDE/ISOMETER SYSTEM (March 21, 1988)
  • K880150 — PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM (March 4, 1988)

Other clearances for product code KIJ

  • K163308 — SMARTO (December 27, 2016)
  • K112599 — INSURGICAL SINGLE USE POWER EQUIPMENT (November 6, 2012)
  • K101563 — SMARTO (December 17, 2010)
  • K972367 — STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT (September 4, 1997)
  • K970378 — STRYKER 2115 REPLACEMENT BATTERY (2115) (April 30, 1997)
  • K960711 — ACUMED BONE GRAFT SYSTEM (May 7, 1996)
  • K951450 — SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY (May 17, 1995)
  • K944488 — S & S ORTHOPEDIC WIRE DRIVER 701 (March 2, 1995)
  • K941285 — ARTHREX GRAFT HARVESTING KIT (November 14, 1994)
  • K933101 — THE OSTEOMED B POWER SYSTEM AND ACCESSORIES (November 7, 1994)

FDA data resources