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510(k) K030608

OTI BONE CEMENT PLUG by Osteoimplant Technology, Inc. — Product Code JDK

K030608 is an FDA 510(k) premarket notification submitted by Osteoimplant Technology, Inc. for the device "OTI BONE CEMENT PLUG". The FDA issued a decision of SESU on June 12, 2003. The device falls under product code JDK (Prosthesis, Hip, Cement Restrictor), a Class II device regulated under 21 CFR 878.3300. Osteoimplant Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
June 12, 2003
Date Received
February 26, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Cement Restrictor
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

Other clearances by Osteoimplant Technology, Inc.

  • K040685 — Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED (January 25, 2005)
  • K041443 — OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM (November 16, 2004)
  • K040225 — OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM (May 6, 2004)
  • K032729 — Z-SERIES MODULAR TOTAL HIP SYSTEM (December 3, 2003)
  • K022779 — OTI UNICONDULAR INTERPOSITIONAL SPACER (November 20, 2002)
  • K021822 — R120 MODULAR TOTAL HIP SYSTEM (July 23, 2002)
  • K012762 — MJS POSTERIOR STABILIZED KNEE SYSTEM (December 11, 2001)
  • K011774 — R120 MODULAR TOTAL HIP SYSTEM (September 5, 2001)
  • K003316 — OTI CERAMIC FEMORAL HEAD SYSTEM (January 19, 2001)
  • K003199 — TRIAD II MODULAR TOTAL HIP SYSTEM (January 10, 2001)

Other clearances for product code JDK

  • K210062 — Mectaplug PE II (April 8, 2021)
  • K061465 — KMI CEMENT RESTRICTOR IMPLANT (October 5, 2006)
  • K061698 — MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR (July 12, 2006)
  • K060247 — LIFE SPINE CEMENT RESTRICTOR (May 11, 2006)
  • K060132 — SPINAL USA CEMENT RESTRICTOR SYSTEM (March 16, 2006)
  • K051371 — INTERBODY INNOVATIONS CEMENT RESTRICTOR (December 6, 2005)
  • K051836 — SKELITE RESORBABLE CEMENT RESTRICTOR (November 21, 2005)
  • K051607 — NOVASPINE CEMENT RESTRICTOR NSCR (October 7, 2005)
  • K052367 — SCIENT'X CEMENT RESTRICTOR (October 5, 2005)
  • K041382 — POLYGRAFT BGS; BONE GRAFT SUBSTITUTE (June 17, 2005)

FDA data resources