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510(k) K011715

MACROPORE IB RESORBABLE PLUG by Macropore Biosurgery, Inc. — Product Code JDI

Clearance Details

Decision
SESU ()
Decision Date
August 27, 2001
Date Received
June 4, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
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)

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