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510(k) K091912

B-GENIN AND R-GENIN by Berkeley Advanced Biomaterials, Inc. — Product Code MQV

K091912 is an FDA 510(k) premarket notification submitted by Berkeley Advanced Biomaterials, Inc. for the device "B-GENIN AND R-GENIN". The FDA issued a decision of Substantially Equivalent on June 23, 2010. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Berkeley Advanced Biomaterials, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2010
Date Received
June 25, 2009
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

Other clearances by Berkeley Advanced Biomaterials, Inc.

  • K170917 — Bi-Ostetic Bioactive Glass Foam (October 30, 2017)
  • K113791 — B-GENIN, R-GENIN (March 15, 2012)
  • K092046 — BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY (March 24, 2010)
  • K053213 — BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM (July 6, 2006)
  • K051914 — GENEROS 80, GENEROS 60 (November 3, 2005)
  • K051695 — MARROW PLUS (M+) (July 19, 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)

Other clearances for product code MQV

  • K260364 — Device 300419 Strip (June 2, 2026)
  • K252797 — JAZBI™ Resorbable Bone Void Filler (May 26, 2026)
  • K261008 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioa (April 24, 2026)
  • K253524 — Adaptos®Fuse Bone Graft (February 17, 2026)
  • K253147 — FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft S (October 22, 2025)
  • K251522 — Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (October 13, 2025)
  • K252085 — Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix (September 30, 2025)
  • K251556 — Device 300423 Granules (July 17, 2025)
  • K251720 — OsteoFlo HydroFiber (July 2, 2025)
  • K251193 — Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft (June 12, 2025)

FDA data resources