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510(k) K021511

CYTOFLEX MESH by Unicare Biomedical, Inc. — Product Code JEY

K021511 is an FDA 510(k) premarket notification submitted by Unicare Biomedical, Inc. for the device "CYTOFLEX MESH". The FDA issued a decision of Substantially Equivalent on August 6, 2002. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Unicare Biomedical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2002
Date Received
May 9, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

Other clearances by Unicare Biomedical, Inc.

  • K151344 — Cytoflex Tefguard Ti-Enforced Membrane (November 19, 2015)
  • K092567 — MODIFICATION TO UNIGRAFT (November 25, 2009)
  • K090612 — BENACEL (July 24, 2009)
  • K090083 — CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 (March 23, 2009)
  • K080532 — BENACEL, MODELS C-001, C-002 AND C-005 (November 12, 2008)
  • K020720 — OSSIFORM (May 7, 2002)
  • K012144 — CYTOFLEX (October 1, 2001)
  • K003457 — UNIGRAFT (January 9, 2001)
  • K993784 — UNIGRAFT (January 27, 2000)
  • K982699 — UNIGRAFE (October 20, 1998)

Other clearances for product code JEY

  • K252246 — Leforte MMF System (April 2, 2026)
  • K253373 — Southern Craniomaxillofacial (CMF) System (December 19, 2025)
  • K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsor (November 7, 2025)
  • K241314 — KLS Martin Oral-Max Implants MR Conditional (bundled) (August 16, 2024)
  • K240651 — MRI Universal (July 12, 2024)
  • K233874 — tmCMF Solution (July 11, 2024)
  • K232889 — METICULY Patient-specific titanium maxillofacial mesh implant (April 30, 2024)
  • K232350 — Stryker Facial iD System (January 13, 2024)
  • K230398 — MedCAD® AccuPlate® 3DTi Patient-Specific Plating System (September 26, 2023)
  • K230733 — Stryker Resorbable Fixation System (August 5, 2023)

FDA data resources