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510(k) K950165

INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS by Interpore Intl. — Product Code LYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1995
Date Received
January 17, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Grafting Material, Synthetic
Device Class
Class II
Regulation Number
872.3930
Review Panel
DE
Submission Type

A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.

Other clearances by Interpore Intl.

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  • K972842 — INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE (October 30, 1997)
  • K971036 — ODONTIT AUTOGENOUS BONE COLLECTION DEVICE (June 3, 1997)
  • K960945 — IMZ MEMBRANE TACK SYSTEM (May 24, 1996)
  • K960371 — INTERPORE THREADED IMPLANT (March 8, 1996)
  • K955492 — INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT (January 30, 1996)
  • K952167 — IMZ BONE TACK SYSTEM (November 21, 1995)
  • K922872 — INTERPORE CYLINDRICAL HEX HYDROXYAPATITE COATED IMPLANT, 3.3 MM DIAM. (July 25, 1994)
  • K922732 — INTERPORE CYLINDRICAL HEX IMPLANT, 3.3 MM DIAMETER (February 10, 1994)

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