Home / 510(k) Clearances / K030266

510(k) K030266

CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ by Berkeley Advanced Biomaterials, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2003
Date Received
January 27, 2003
Clearance Type
Special
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)
  • K091912 — B-GENIN AND R-GENIN (June 23, 2010)
  • 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)

Other clearances for product code MQV

  • 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)
  • K243949 — OsteoFlo HydroFiber (May 28, 2025)
  • K243474 — MagnetOs MIS (May 23, 2025)
  • K250141 — Synthecure Synthetic Calcium Sulfate (May 16, 2025)