Bacterin International, Inc.
FDA Regulatory Profile
Bacterin International, Inc. appears in FDA public data with 5 recalls, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1396-2015, Class II) was initiated on March 9, 2015. Its most recent 510(k) clearance was granted on August 18, 2015.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1396-2015 | Class II | Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge | March 9, 2015 |
| Z-1680-2014 | Class II | Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two d | May 15, 2014 |
| Z-1138-2013 | Class II | OsteoSelect DBM Putty Product Usage: Orthopedic bone filler | February 21, 2013 |
| Z-0936-2013 | Class II | Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coate | January 28, 2013 |
| Z-0800-2013 | Class II | Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-66 | April 18, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K150621 | OsteoSelect PLUS Demineralized Bone Matrix Putty | August 18, 2015 |
| K130498 | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY | May 31, 2013 |
| K091321 | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY | September 11, 2009 |
| K063245 | ELUTIA COATED CLOSED SURGICAL WOUND DRAIN | November 28, 2007 |