OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY— 510(k) K091321
Substantially EquivalentBacterin International, Inc.
FDA 510(k) clearance K091321 for OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY, Substantially Equivalent on 2009-09-11. Applicant: Bacterin International, Inc.. Device class: 2.
Clearance details
- Applicant
- Bacterin International, Inc.
- Product code
- Code MQV
- Device class
- Class 2
- Regulation
- 21 CFR 888.3045
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Belgrade, MT, US
Recent devices under product code MQV
view allMore clearances from Bacterin International, Inc.
view allAdverse events under product code MQV
product code MQV- Death
- 6
- Injury
- 435
- Total
- 441
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K091321
K-number listed on FDA's recall record- Z-1138-2013 — OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
- Z-0800-2013 — Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects. On 07/12/2012 an additional expired product was discovered by a Bacterin sales rep. B100078-908 with expiration date 04/27/2012
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091321.
Data sourced from openFDA. This site is unofficial and independent of the FDA.