Company ยท US
Bacterin International, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2015. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 18, 2015 | K150621 | OsteoSelect PLUS Demineralized Bone Matrix Putty Bacterin International, Inc. | MQV |
| May 31, 2013 | K130498 | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY Bacterin International, Inc. | MBP |
| Sep 11, 2009 | K091321 | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY Bacterin International, Inc. | MQV |
| Nov 28, 2007 | K063245 | ELUTIA COATED CLOSED SURGICAL WOUND DRAIN Bacterin International, Inc. | OEI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2015 | Bacterin International, Inc. Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in the subchondral region of articulating joints.
The Instrument Ki Terminated |
LXH | None listed |
| Jun 2, 2014 | Bacterin International, Inc. Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***"
Two different sizes, 10 units per box:
19 Fr Round Hubless part number 7110;
24 Fr Round Hubless part num Terminated |
OEI | K063245 |
| Apr 17, 2013 | Bacterin International, Inc. OsteoSelect DBM Putty
Product Usage:
Orthopedic bone filler Terminated |
MBP | K091321 |
| Mar 11, 2013 | Bacterin International, Inc. Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound draina Terminated |
OEI | K063245 |
| Feb 11, 2013 | Bacterin International, Inc. 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# B0900 Terminated |
MBP | K091321 |