Home / 510(k) Clearances / K811205

510(k) K811205

MOLDED POLYSULFONE TRIAL PROSTHESIS by Shannon Group — Product Code HWT

K811205 is an FDA 510(k) premarket notification submitted by Shannon Group for the device "MOLDED POLYSULFONE TRIAL PROSTHESIS". The FDA issued a decision of Substantially Equivalent on May 21, 1981. The device falls under product code HWT (Template), a Class I device regulated under 21 CFR 888.4800. Shannon Group has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1981
Date Received
May 1, 1981
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 Shannon Group

  • K820156 — THEIR ELECTRO SURGICAL COUTERY PENCIL (February 18, 1982)

Other clearances for product code HWT

  • K974406 — ORTHOPLAN (February 18, 1998)
  • K960685 — ORTHODOC PREOPERATIVE PLANNER MODEL 500 (January 17, 1997)
  • K894228 — KRONNER SPHERICAL CUTTERS (July 23, 1990)
  • 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)
  • K781091 — KNEE INSTRUMENTATION, CONDYLAR (July 17, 1978)
  • K771710 — WORRELL PATELLA TEMPLATE (October 6, 1977)
  • K771709 — WORRELL TRIAL PATELLA (October 6, 1977)

FDA data resources