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510(k) K894228

KRONNER SPHERICAL CUTTERS by Kronner Medical — Product Code HWT

K894228 is an FDA 510(k) premarket notification submitted by Kronner Medical for the device "KRONNER SPHERICAL CUTTERS". The FDA issued a decision of Substantially Equivalent on July 23, 1990. The device falls under product code HWT (Template), a Class I device regulated under 21 CFR 888.4800. Kronner Medical has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1990
Date Received
June 19, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Template
Device Class
Class I
Regulation Number
888.4800
Review Panel
OR
Submission Type

Other clearances by Kronner Medical

  • K895171 — BLOOD GAS SAFETY SYRINGE (November 7, 1989)
  • K895173 — SKELETAL FIXATION PIN (September 12, 1989)
  • K895172 — KRONNER SACRAL PIN GUIDE (September 12, 1989)
  • K871248 — KRONNER COLLES-FOREARM EXTERNAL FIXATION (June 3, 1987)
  • K871249 — KRONNER BI-PLANER TIBIA EXTERNAL FIXATION (May 22, 1987)
  • K871247 — KRONNER UNIVERSAL FRAME EXTERNAL FIXATION (May 22, 1987)

Other clearances for product code HWT

  • K974406 — ORTHOPLAN (February 18, 1998)
  • K960685 — ORTHODOC PREOPERATIVE PLANNER MODEL 500 (January 17, 1997)
  • K870843 — SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA (May 27, 1987)
  • K871323 — ARTHROSCOPIC MENISCAL SUTURE SYSTEM (May 1, 1987)
  • K830360 — 3M OSTEOTOMY GUIDE (March 1, 1983)
  • K811205 — MOLDED POLYSULFONE TRIAL PROSTHESIS (May 21, 1981)
  • K781091 — KNEE INSTRUMENTATION, CONDYLAR (July 17, 1978)
  • K771710 — WORRELL PATELLA TEMPLATE (October 6, 1977)
  • K771709 — WORRELL TRIAL PATELLA (October 6, 1977)

FDA data resources