Home / 510(k) Clearances / K051695

510(k) K051695

MARROW PLUS (M+) by Berkeley Advanced Biomaterials, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2005
Date Received
June 23, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type

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  • K053213 — BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM (July 6, 2006)
  • K051914 — GENEROS 80, GENEROS 60 (November 3, 2005)
  • K050666 — GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, (April 11, 2005)
  • K042636 — BIOPLUS (December 14, 2004)
  • K041889 — TRI-OSTETIC (August 19, 2004)
  • K040405 — CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY (March 5, 2004)

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