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510(k) K812506

THE ARTHROFILE by Dyonics, Inc. — Product Code HTR

K812506 is an FDA 510(k) premarket notification submitted by Dyonics, Inc. for the device "THE ARTHROFILE". The FDA issued a decision of Substantially Equivalent on September 24, 1981. The device falls under product code HTR (Rasp), a Class I device regulated under 21 CFR 878.4800. Dyonics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1981
Date Received
September 1, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rasp
Device Class
Class I
Regulation Number
878.4800
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 HTR

  • K870329 — ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202 (February 13, 1987)
  • K870349 — BIODYNAMICS FEMORAL CANAL BRUSH #1201 (February 13, 1987)
  • K870333 — BIODYNAMICS SMALL JOINT BRUSH #1203 (February 13, 1987)
  • K813093 — RICHARDS ACETABULAR BRUSH (November 20, 1981)
  • K780771 — MICRO RASPS (May 16, 1978)
  • K771016 — INTERMEDULLARY BRUSH (January 12, 1978)
  • K771745 — RASPS FOR SCRAPING BONE (September 28, 1977)
  • K760109 — PROSTHESIS, TOTAL HIP-RASP (July 20, 1976)

FDA data resources