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510(k) K972143

MOA BONE / M-SPHERE by Iop, Inc. — Product Code HPZ

K972143 is an FDA 510(k) premarket notification submitted by Iop, Inc. for the device "MOA BONE / M-SPHERE". The FDA issued a decision of Substantially Equivalent on October 16, 1997. The device falls under product code HPZ (Implant, Eye Sphere), a Class II device regulated under 21 CFR 886.3320. Iop, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1997
Date Received
June 6, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Eye Sphere
Device Class
Class II
Regulation Number
886.3320
Review Panel
OP
Submission Type

Other clearances by Iop, Inc.

  • K090078 — KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT (May 8, 2009)
  • K062252 — MOLTENO3 (September 27, 2006)
  • K053622 — SURGISIS OCULAR GRAFT (March 15, 2006)
  • K010852 — OSMED TISSUE EXPANDER (August 13, 2001)
  • K003646 — SUTUREGROOVE WEIGHT SIZING SET (February 22, 2001)
  • K994289 — SUTUREGROOVE (April 17, 2000)
  • K902489 — MODIFIED MOLTENO(TM) IMPLANTS (August 14, 1990)
  • K890598 — MOLTENO IMPLANT (February 27, 1989)

Other clearances for product code HPZ

  • K212741 — EZYPOR (June 24, 2022)
  • K123764 — DURETTE OCULAR IMPLANT (January 31, 2013)
  • K110554 — BIOCERAMIC ORBITAL IMPLANT, ORBTEX (November 2, 2011)
  • K112176 — SILICONE SPHERES (September 15, 2011)
  • K083342 — ORBITAL RECONSTRUCTIVE IMPLANT II (March 12, 2009)
  • K082850 — EYE SPHERES (February 27, 2009)
  • K073293 — DURETTE IMPLANT (March 19, 2008)
  • K071335 — MEDPOR ATTRACTOR IMPLANT (August 8, 2007)
  • K070130 — ORBITAL RECONSTRUCTIVE IMPLANT (April 19, 2007)
  • K053298 — ALPHASPHERE ORBITAL IMPLANT (May 9, 2006)

FDA data resources