Osteogenics Biomedical, Inc.
FDA Regulatory Profile
Osteogenics Biomedical, Inc. appears in FDA public data with 1 recall, 8 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0113-2017, Class II) was initiated on September 7, 2016. Its most recent 510(k) clearance was granted on January 23, 2021.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 8
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0113-2017 | Class II | Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non | September 7, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K201187 | Cytoplast Titanium-Reinforced PTFE Membranes | January 23, 2021 |
| K171774 | RPM Reinforced PTFE Mesh | October 19, 2017 |
| K093719 | PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# | March 1, 2010 |
| K072076 | CYTOPLAST PTFE SUTURE | October 31, 2007 |
| K013764 | IMMIX BONE GRAFT EXTENDER | May 16, 2002 |
| K003028 | CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC | November 24, 2000 |
| K993610 | CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250 | March 2, 2000 |
| K984230 | OSTEO-MESH TM-300 | February 4, 1999 |