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510(k) K000696

MACROPOREMX MANDIBULAR FIXATION SYSTEM by Macropore Biosurgery, Inc. — Product Code JEY

K000696 is an FDA 510(k) premarket notification submitted by Macropore Biosurgery, Inc. for the device "MACROPOREMX MANDIBULAR FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 19, 2000. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Macropore Biosurgery, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2000
Date Received
March 1, 2000
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 Macropore Biosurgery, Inc.

  • K042261 — MACROPORE PURICEL LIPOPLASTY SYSTEM (September 20, 2004)
  • K041105 — MACROPORE HYDROSORB SPINE SYSTEM (July 28, 2004)
  • K031955 — MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET (September 22, 2003)
  • K031785 — MACROPORE CARDIO-WRAP (TS) (September 4, 2003)
  • K024169 — MACROPORE OS RECONSTRUCTION (July 1, 2003)
  • K023643 — MACROPORE SURGICAL BARRIER FILM (February 21, 2003)
  • K021164 — MACROPORE OS TRAUMA (July 1, 2002)
  • K012025 — MACROPORE SURGIWRAP (TS) (December 3, 2001)
  • K012769 — MACROPORE ENT RECONSTRUCTION FILM (October 25, 2001)
  • K012413 — MACROPORE FX, PS, NS, LP (September 18, 2001)

Other clearances for product code JEY

  • K260137 — KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions (August 17, 2026)
  • K253206 — METICULY Patient-specific CMF solution (July 25, 2026)
  • 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)

FDA data resources