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510(k) K843121

GUIDE TO THE KNEE by Dyonics, Inc. — Product Code BWN

K843121 is an FDA 510(k) premarket notification submitted by Dyonics, Inc. for the device "GUIDE TO THE KNEE". The FDA issued a decision of Substantially Equivalent on September 7, 1984. The device falls under product code BWN (Table And Attachments, Operating-Room), a Class I device regulated under 21 CFR 878.4950. Dyonics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1984
Date Received
August 8, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table And Attachments, Operating-Room
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
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 BWN

  • K942699 — AIRFRAME SURGICAL DRAPE SUPPORT (July 13, 1994)
  • K935441 — INFINITECH BREATH EZ (February 7, 1994)
  • K925005 — ISI SELF-SUPPORTING ARM (April 29, 1993)
  • K922288 — HOLDER, PEDIATRIC POSITION (February 10, 1993)
  • K910783 — SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M (April 2, 1991)
  • K902865 — BAUMER SURGICAL TABLE (September 10, 1990)
  • K884558 — IOP ADJUSTABLE STIRRUP (November 17, 1988)
  • K875291 — SPINAL SURGERY FRAME (January 22, 1988)
  • K873272 — ENDOSCOPY TABLE 1532 ENDOSTAR (September 8, 1987)
  • K860177 — ALLEN UNIVERSAL STIRRUP (February 11, 1986)

FDA data resources