Company ยท US
Regeneration Technologies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2008. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
27recalls (0 in 12 months)
20recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 30, 2008 | K080418 | REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST Regeneration Technologies, Inc. | NUN |
| Jan 25, 2008 | K072238 | BIOSET XCH Regeneration Technologies, Inc. | MQV |
| Oct 24, 2007 | K072327 | CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON Regeneration Technologies, Inc. | MQV |
| May 9, 2007 | K063584 | STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937 Regeneration Technologies, Inc. | HWC |
| Sep 6, 2006 | K060180 | BIOSET XC Regeneration Technologies, Inc. | MBP |
| Feb 23, 2006 | K060253 | STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST. Regeneration Technologies, Inc. | HWC |
| Nov 16, 2005 | K052405 | STERLING INTERFERENC SCREW HT Regeneration Technologies, Inc. | HWC |
| Aug 15, 2005 | K051615 | STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES Regeneration Technologies, Inc. | MQV |
| Jun 9, 2005 | K050767 | STERLING INTERFERENCE SCREW ST Regeneration Technologies, Inc. | HWC |
| Feb 16, 2005 | K043421 | OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC Regeneration Technologies, Inc. | MQV |
| Feb 10, 2005 | K043420 | OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE Regeneration Technologies, Inc. | MQV |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 28, 2006 | Regeneration Technologies, Inc. Osteofil RT, ICM Allograft Paste in varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | None listed |
| Mar 28, 2006 | Regeneration Technologies, Inc. Osteofil ICM Moldable Strip of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | None listed |
| Mar 28, 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 |
| Mar 28, 2006 | Regeneration Technologies, Inc. Osteofil Allograft Paste (Bio) of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | None listed |
| Mar 28, 2006 | Regeneration Technologies, Inc. Osteofil Allograft, 5cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | None listed |
| Mar 28, 2006 | Regeneration Technologies, Inc. Osteofil + RT Allograft Paste 10cc. 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 2.0 cc Opteform RT. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | K043421 |
| 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 | K043420 |
| 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 | K043420 |
| 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 | K043420 |
| 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 | K043420 |
| 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 | K043420 |
| Feb 7, 2006 | Regeneration Technologies, Inc. Product is RTI Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | K043421 |
| 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 | K043420 |
| 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 | K043420 |
| 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 | K043420 |
| 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 | K043420 |
| 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 | K043420 |
| Feb 7, 2006 | Regeneration Technologies, Inc. Osteofil RT, ICM Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | K043421 |
| Feb 7, 2006 | Regeneration Technologies, Inc. Osteofil ICM Moldable Strip of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | K043421 |
| 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 | K043420 |
| Feb 7, 2006 | Regeneration Technologies, Inc. Osteofil Allograft Paste (Bio) 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 + RT Allograft Paste in varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | K043421 |
| Feb 7, 2006 | Regeneration Technologies, Inc. OPTEFORM RT Moldable Allograft of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | K043421 |
| Feb 7, 2006 | Regeneration Technologies, Inc. Product is OPTEFORM Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | K043421 |
| Feb 7, 2006 | Regeneration Technologies, Inc. Product is OPTEFORM Allografts of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | K043421 |
| 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 | K043420 |