Bi-Ostetic Bioactive Glass Foam— 510(k) K170917

Clearance details

Applicant

Berkeley Advanced Biomaterials

Product code

Code MQV

Device class

Class 2

Regulation

21 CFR 888.3045

Advisory panel

Orthopedic

Date received

2017-03-29

Decision date

2017-10-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Berkeley, CA, US

• K262230 — Mg OSTEOREVIVE; Mg OSTEOCRETE2026-09-11
• K260364 — Device 300419 Strip2026-06-02
• K252797 — JAZBI Resorbable Bone Void Filler2026-05-26
• K261008 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip +7 more2026-04-24
• K253524 — Adaptos®Fuse Bone Graft2026-02-17

• K260711 — Accelagen Plus Surgical Matrix, 1cc (CG-01AP) +4 more2026-08-27

Death

6

Injury

435

Total

441

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0540-2026 — Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure.Class II·Ongoing·Berkeley Advanced Biomaterials, LLC·20250902

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170917.