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510(k) K871323

ARTHROSCOPIC MENISCAL SUTURE SYSTEM by Orthopedic Systems, Inc. — Product Code HWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1987
Date Received
April 3, 1987
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

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  • K830360 — 3M OSTEOTOMY GUIDE (March 1, 1983)
  • K811205 — MOLDED POLYSULFONE TRIAL PROSTHESIS (May 21, 1981)
  • K781091 — KNEE INSTRUMENTATION, CONDYLAR (July 17, 1978)
  • K771709 — WORRELL TRIAL PATELLA (October 6, 1977)
  • K771710 — WORRELL PATELLA TEMPLATE (October 6, 1977)