Medical Device Manufacturer · US , Alachua , FL

Regeneration Technologies, Inc. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2005

Recent clearances: REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST, BIOSET XCH, CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON

View 11 510(k) Devices ↓

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Regeneration Technologies, Inc. Orthopedic ✕

10 devices

1-10 of 10

Cleared Jan 25, 2008

Orthopedic · 165d

Cleared Oct 24, 2007

CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON

Orthopedic · 65d

Cleared May 09, 2007

STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL...

Orthopedic · 159d

Cleared Sep 06, 2006

Orthopedic · 226d

Cleared Feb 23, 2006

STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.

Orthopedic · 22d

Cleared Nov 16, 2005

STERLING INTERFERENC SCREW HT

Orthopedic · 76d

Cleared Aug 15, 2005

STERLING CANCELLOUS CHIPS

Orthopedic · 59d

Cleared Jun 09, 2005

STERLING INTERFERENCE SCREW ST

Orthopedic · 76d

Cleared Feb 16, 2005

OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC

Orthopedic · 65d

Cleared Feb 10, 2005

OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE

Orthopedic · 59d