510(k) K043420 ยท MQV Filler, Bone Void, Calcium Compound
OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE
| Applicant | Regeneration Technologies, Inc., Alachua FL, US |
| Decision | Substantially Equivalent, Feb 10, 2005 |
| Received | Dec 13, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043420
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 23, 2011 | RTI Biologics, Inc. ***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, FL, USA 32615***Distributed by: SpinalGraft Technologies, LLC 4340 Swinnea Road STE 39 Memphis, TN 38118***OSTEOFIL DBM Paste, 5cc Tissue ID Terminated |
MQV | None listed |
| Feb 7, 2006 | Regeneration Technologies, Inc. Product is 1.0 cc Regenaform RT. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | None listed |
| Feb 7, 2006 | Regeneration Technologies, Inc. Osteofil IC Syringeable of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | None listed |
| Feb 7, 2006 | Regeneration Technologies, Inc. OSTEOFIL DBM Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | None listed |
| Feb 7, 2006 | Regeneration Technologies, Inc. OsteoPack 3 FZ 22cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | None listed |
| Feb 7, 2006 | Regeneration Technologies, Inc. Product is Regenafil IC. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | None listed |
| Feb 7, 2006 | Regeneration Technologies, Inc. Product is REGENAFORM RT Allograft Paste, 1cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | None listed |
| Feb 7, 2006 | Regeneration Technologies, Inc. Product is REGENAFORM Allograft Moldable Blocks, of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | None listed |
| Feb 7, 2006 | Regeneration Technologies, Inc. Product is REGENAFIL Allograft Paste, Syringe, 0.5cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | None listed |
| Feb 7, 2006 | Regeneration Technologies, Inc. Product is 1.0cc flowable paste from donor approved for distribution in Italy. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT U Terminated |
MQV | None listed |
| Feb 7, 2006 | Regeneration Technologies, Inc. Product is OPTEFIL Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | None listed |
| Feb 7, 2006 | Regeneration Technologies, Inc. Product is OPTEFIL Allograft Paste, Syringe of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | None listed |
| Feb 7, 2006 | Regeneration Technologies, Inc. Product is OPTEFORM Allograft Full Disc, 5 x 90mm, 32cc, Frozen. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.