Home / 510(k) Clearances / K073303

510(k) K073303

NORIAN DRILLABLE by Synthes (Usa) — Product Code OIS

K073303 is an FDA 510(k) premarket notification submitted by Synthes (Usa) for the device "NORIAN DRILLABLE". The FDA issued a decision of SESU on July 2, 2008. The device falls under product code OIS (Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation), a Class II device regulated under 21 CFR 888.3045. Synthes (Usa) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
July 2, 2008
Date Received
November 23, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type

To fill traumatic or surgically-created defects not intrinsic to the stability of the bony structure. It is delivered to the defect and resorbs over time to be replaced by bone. Not for screw augmentation.

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