Company ยท US
Isotis Orthobiologics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2009. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
3recalls (1 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 10, 2009 | K091193 | ACCELL EVO3C Isotis Orthobiologics, Inc. | MBP |
| Sep 24, 2008 | K081817 | ACCELL TBM-R Isotis Orthobiologics, Inc. | MBP |
| Oct 15, 2007 | K070751 | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY Isotis Orthobiologics, Inc. | MQV |
| Dec 5, 2005 | K050642 | ORTHOBLAST II PUTTY AND PASTE Isotis Orthobiologics, Inc. | MBP |
| Sep 7, 2005 | K052098 | CONNEXUS, .5CC, MODEL 023000-005 Isotis Orthobiologics, Inc. | MQV |
| Jul 29, 2005 | K043573 | DYNAGRAFT II DENTAL Isotis Orthobiologics, Inc. | NUN |
| Jul 7, 2005 | K050690 | CONNEXUS Isotis Orthobiologics, Inc. | MQV |
| Mar 25, 2005 | K040419 | DYNAGRAFT II Isotis Orthobiologics, Inc., NL | MQV |
| Oct 20, 2004 | K042706 | OSSATURA DENTAL Isotis Orthobiologics, Inc. | LYC |
| Sep 16, 2004 | K041991 | ASPIREX - BONE MARROW ASPIRATE KIT Isotis Orthobiologics, Inc. | FMF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2026 | IsoTis OrthoBiologics, Inc. OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095.
Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095 Open, Classified |
MQV | K172130 |
| Jan 16, 2025 | IsoTis OrthoBiologics, Inc. OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100. Open, Classified |
MQV | K242273 |
| Jan 15, 2025 | IsoTis OrthoBiologics, Inc. OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01. Open, Classified |
MQV | K242273 |