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510(k) K980138

SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT by Spectrum Designs, Inc. — Product Code FWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1998
Date Received
January 15, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Chin, Internal
Device Class
Class II
Regulation Number
878.3550
Review Panel
SU
Submission Type

Other clearances by Spectrum Designs, Inc.

  • K992522 — SPECTRUM DESIGNS SPECTRAGEL (October 26, 1999)
  • K982688 — SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK (October 13, 1998)
  • K980444 — SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT (May 6, 1998)
  • K980463 — SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT (May 6, 1998)
  • K980446 — SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT (May 6, 1998)
  • K980445 — SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT (May 6, 1998)
  • K980462 — SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT (May 6, 1998)
  • K980461 — SPECTRUM DESIGNS CLEFT CHIN IMPLANT (March 4, 1998)
  • K980140 — SPECTRUM DESIGNS MEDIAL MALAR IMPLANT (March 3, 1998)
  • K980139 — SPECTRUM DESIGNS PROFILE MALAR IMPLANT (March 3, 1998)

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  • K153508 — Stryker CMF MEDPOR Customized Implant (February 5, 2016)
  • K152463 — SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant (January 20, 2016)
  • K143173 — Stryker CMF MEDPOR Customized Implant (March 23, 2015)
  • K141027 — 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, S (July 10, 2014)
  • K121315 — STRYKER CMF MEDPOR CUSTOMIZED IMPLANT (November 1, 2012)