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510(k) K970957

OSTEONICS RESTORATION ACETABULAR RING by Osteonics Corp. — Product Code JDJ

K970957 is an FDA 510(k) premarket notification submitted by Osteonics Corp. for the device "OSTEONICS RESTORATION ACETABULAR RING". The FDA issued a decision of Substantially Equivalent on June 3, 1997. The device falls under product code JDJ (Mesh, Surgical, Acetabular, Hip, Prosthesis), a Class II device regulated under 21 CFR 878.3300. Osteonics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1997
Date Received
March 17, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Acetabular, Hip, Prosthesis
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

Other clearances by Osteonics Corp.

  • K983657 — OSTEONICS SERIES 7000 AD TIBIAL TRAY (April 6, 2000)
  • K980070 — OSTEONICS HA-COATED DEVICES (July 23, 1999)
  • K984375 — OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY (April 30, 1999)
  • K982798 — OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM (March 25, 1999)
  • K984585 — OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE (February 24, 1999)
  • K990203 — OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS (February 18, 1999)
  • K990158 — OSTEONICS COMBINATION SCREW RING/BLOCKER (February 1, 1999)
  • K984302 — OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS (December 18, 1998)
  • K984353 — OSTEO 9MM IC TIBIAL NAIL (December 16, 1998)
  • K983502 — OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM (December 16, 1998)

Other clearances for product code JDJ

  • K972760 — LINK, ACETABULAR REVISION MESH CUP (October 22, 1997)
  • K963940 — EXETER MESH (February 13, 1997)
  • K962541 — REFLECTION ACETABULAR REINFORCEMENT RINGS (September 17, 1996)
  • K962007 — PROTRUSION CAGES (August 1, 1996)
  • K925883 — OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS (June 15, 1993)
  • K890450 — INTERMEDICS APR(TM) II FEMORAL COMPONENT (August 9, 1989)

FDA data resources