Isotis Orthobiologics, Inc.
Isotis Orthobiologics, Inc. holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2009, with 3 FDA device recalls on record.
Top product codes for Isotis Orthobiologics, Inc.
FDA recalls by Isotis Orthobiologics, Inc.
- Z-2820-2026 — OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
- Z-0955-2025 — OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
- Z-0919-2025 — OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Isotis Orthobiologics, Inc.
- K091193 — ACCELL EVO3C
- K081817 — ACCELL TBM-R
- K070751 — ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY
- K050642 — ORTHOBLAST II PUTTY AND PASTE
- K052098 — CONNEXUS, .5CC, MODEL 023000-005
- K043573 — DYNAGRAFT II DENTAL
- K050690 — CONNEXUS
- K040419 — DYNAGRAFT II
- K042706 — OSSATURA DENTAL
- K041991 — ASPIREX - BONE MARROW ASPIRATE KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.