Atlas FDA

OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE

FDA 510(k) clearance K043420 · decided 2005-02-10

Clearance details

K-number
K043420
Device name
OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE
Applicant
Regeneration Technologies, Inc.
Decision
Substantially Equivalent
Date received
2004-12-13
Decision date
2005-02-10
Days to decision
59 days
Clearance type
Traditional
Product code
MQV
Device class
2
Regulation number
888.3045
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Alachua, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, FL, USA 32615***Distributed by: recall (Z-2634-2011)RTI Biologics, Inc.2011-06-23
Product is 1.0 cc Regenaform RT. Product is labeled in part: ''***Processed at: Regenerati recall (Z-0481-06)Regeneration Technologies, Inc.2006-02-07
Osteofil IC Syringeable of varying sizes. Product is labeled in part: ''***Processed at: R recall (Z-0487-06)Regeneration Technologies, Inc.2006-02-07
OSTEOFIL DBM Paste of varying sizes. Product is labeled in part: ''***Processed at: Regene recall (Z-0490-06)Regeneration Technologies, Inc.2006-02-07
OsteoPack 3 FZ 22cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOG recall (Z-0491-06)Regeneration Technologies, Inc.2006-02-07
Product is Regenafil IC. Product is labeled in part: ''***Processed at: Regeneration TECHN recall (Z-0492-06)Regeneration Technologies, Inc.2006-02-07
Product is REGENAFORM RT Allograft Paste, 1cc. Product is labeled in part: ''***Processed recall (Z-0493-06)Regeneration Technologies, Inc.2006-02-07
Product is REGENAFORM Allograft Moldable Blocks, of varying sizes. Product is labeled in p recall (Z-0494-06)Regeneration Technologies, Inc.2006-02-07
Product is REGENAFIL Allograft Paste, Syringe, 0.5cc. Product is labeled in part: ''***Pro recall (Z-0496-06)Regeneration Technologies, Inc.2006-02-07
Product is 1.0cc flowable paste from donor approved for distribution in Italy. Product is recall (Z-0497-06)Regeneration Technologies, Inc.2006-02-07
Product is OPTEFIL Allograft Paste of varying sizes. Product is labeled in part: ''***Proc recall (Z-0498-06)Regeneration Technologies, Inc.2006-02-07
Product is OPTEFIL Allograft Paste, Syringe of varying sizes. Product is labeled in part: recall (Z-0499-06)Regeneration Technologies, Inc.2006-02-07
Product is OPTEFORM Allograft Full Disc, 5 x 90mm, 32cc, Frozen. Product is labeled in par recall (Z-0500-06)Regeneration Technologies, Inc.2006-02-07