Rti Surgical, Inc.
Rti Surgical, Inc. holds FDA 510(k) medical device clearances, first cleared 2014, most recent 2025, with 3 FDA device recalls on record.
Top product codes for Rti Surgical, Inc.
FDA recalls by Rti Surgical, Inc.
- Z-1441-2017 — RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
- Z-0939-2014 — ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USA***Manufacturer: RTI Biologicals, Inc. 11621 Research Circle, Alachua, FL 32615 USA.
- Z-0627-2014 — C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devices that are intended to stabilize a cervical spinal segment to promote fusion in order to restrict motion and decrease pain. They are intended for use with supplemental fixation and autograft. These implants are manufactured from PEEK (Polyaryletheretherketone) polymer with tantalum marker pins for radiographic visualization.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Rti Surgical, Inc.
- K253145 — Pre-Sutured Tendon
- K241555 — Moldable Bone Void Filler and Moldable Bone Void Filler + CCC
- K230036 — Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )
- K172343 — Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology
- K163673 — Fortilink-C with TETRAfuse 3D Technology
- K142070 — FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS
- K132850 — BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM
Data sourced from openFDA. This site is unofficial and independent of the FDA.