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510(k) K811209

JACOB WIRZ TRANSFIXATION PIN by Colmed, Ltd. — Product Code ELS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1981
Date Received
May 1, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Endodontic Stabilizing
Device Class
Class II
Regulation Number
872.3890
Review Panel
DE
Submission Type

Other clearances by Colmed, Ltd.

  • K810636 — VARIODRAIN (May 1, 1981)
  • K810117 — HALOGEN HEADLIGHT SYSTEM (February 10, 1981)
  • K801208 — HOLLOW BASKET TITANIUM DENTAL IMPLANT (May 28, 1980)
  • K801006 — CHARNLEY DESIGN HIP PROSTHESIS (May 20, 1980)
  • K800762 — PS3 TITANIUM SCREW DENTAL IMPLANT (May 14, 1980)
  • K792241 — PELIMIT (November 30, 1979)

Other clearances for product code ELS

  • K972985 — SPLINT IT (September 24, 1997)
  • K961704 — MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM (July 26, 1996)
  • K922673 — FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING (February 25, 1994)
  • K834363 — ENDIX RADICULAR BIOCERAMIC PIN (February 27, 1984)
  • K801525 — ZEST ENDODONTIC STABILIZER (July 21, 1980)