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510(k) K081747

MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM by Synthes (Usa) — Product Code NEI

K081747 is an FDA 510(k) premarket notification submitted by Synthes (Usa) for the device "MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM". The FDA issued a decision of Substantially Equivalent on September 5, 2008. The device falls under product code NEI (Prosthesis, Condyle, Mandibular, Temporary), a Class II device regulated under 21 CFR 872.4770. Synthes (Usa) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2008
Date Received
June 19, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Condyle, Mandibular, Temporary
Device Class
Class II
Regulation Number
872.4770
Review Panel
DE
Submission Type

Other clearances by Synthes (Usa)

  • K180821 — TruMatch Graft Cage - Long Bone (December 21, 2018)
  • K152239 — Zero-P Natural Plate System (December 2, 2015)
  • K131984 — SYNTHES SYNSONIC ULNA NAIL (March 31, 2014)
  • K130146 — SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM (May 20, 2013)
  • K120275 — SYNTHES ACIS/VERTEBRAL SPACER CR (May 25, 2012)
  • K111667 — SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (December 5, 2011)
  • K111540 — SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (August 8, 2011)
  • K110789 — SYNTHES STERNAL ZIPFIX SYSTEM (July 28, 2011)
  • K103002 — SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM (March 2, 2011)
  • K103243 — 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM (January 21, 2011)

Other clearances for product code NEI

  • K133285 — STRYKER TEMPORARY CONDYLAR PROSTHESIS (April 9, 2014)
  • K063181 — SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM (January 5, 2007)
  • K031701 — OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM (July 8, 2004)
  • K002790 — ADD-ON CONDYLE (August 6, 2001)
  • K990667 — KLS-MARTIN TEMPORARY CONDYLAR IMPLANT (July 27, 2001)
  • K990637 — SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD (October 22, 1999)

FDA data resources