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510(k) K052483

SYNTHES (USA) SPHERICAL WASHERS by Synthes (Usa) — Product Code NDG

K052483 is an FDA 510(k) premarket notification submitted by Synthes (Usa) for the device "SYNTHES (USA) SPHERICAL WASHERS". The FDA issued a decision of Substantially Equivalent on November 4, 2005. The device falls under product code NDG (Washer, Bolt, Nut, Non-Spinal, Metallic), a Class II device regulated under 21 CFR 888.3030. Synthes (Usa) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2005
Date Received
September 9, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Washer, Bolt, Nut, Non-Spinal, Metallic
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
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)

FDA data resources