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IsoTis OrthoBiologics, Inc.

3 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis recall (Z-2820-2026)IsoTis OrthoBiologics, Inc.2026-07-28
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Dem recall (Z-0955-2025)IsoTis OrthoBiologics, Inc.2025-01-16
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01. recall (Z-0919-2025)IsoTis OrthoBiologics, Inc.2025-01-15

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Every clearance here is in the API, with alerts when new ones post.