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510(k) K900930

SPIVEY-ALLEN ORBITAL FLOOR IMPLANT by Oculo Plastik, Inc. — Product Code HQX

K900930 is an FDA 510(k) premarket notification submitted by Oculo Plastik, Inc. for the device "SPIVEY-ALLEN ORBITAL FLOOR IMPLANT". The FDA issued a decision of Substantially Equivalent on May 15, 1990. The device falls under product code HQX (Implant, Orbital, Extra-Ocular), a Class II device regulated under 21 CFR 886.3340. Oculo Plastik, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1990
Date Received
February 27, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Orbital, Extra-Ocular
Device Class
Class II
Regulation Number
886.3340
Review Panel
OP
Submission Type

Other clearances by Oculo Plastik, Inc.

  • K112176 — SILICONE SPHERES (September 15, 2011)
  • K073293 — DURETTE IMPLANT (March 19, 2008)
  • K040689 — EYE SPHERE IMPLANTS (June 10, 2004)
  • K934834 — EPTFE SHEET COVERING FOR OCULAR IMPLANT (May 5, 1994)
  • K915630 — OPHTIMPLANT (March 2, 1992)
  • K901002 — O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES (May 22, 1990)
  • K900929 — PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL (May 18, 1990)
  • K900928 — COX MALAR EMINENCE IMPLANTS (May 15, 1990)
  • K900927 — CODERE-DURETTE ORBITAL FLOOR IMPLANT (May 15, 1990)
  • K900081 — NEW ALLEN IMPLANT (March 23, 1990)

Other clearances for product code HQX

  • K023481 — MICROVISION SCLERAL BUCKLING COMPONENTS (January 8, 2003)
  • K983581 — OCU-GUARD AND OCU-GUARD SUPPLE (November 6, 1998)
  • K980816 — RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES (September 18, 1998)
  • K963219 — RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND S (October 28, 1996)
  • K950806 — SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS (June 5, 1996)
  • K950599 — STORS SCLERAL SPONGE II (LINCOFF DESIGN) (March 2, 1995)
  • K945172 — VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS (January 17, 1995)
  • K902308 — TAMCENAN OCULAR EXPLANTS AND BANDS (June 19, 1990)
  • K901002 — O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES (May 22, 1990)
  • K900929 — PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL (May 18, 1990)

FDA data resources