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Rti Surgical, Inc.

Last updated May 24, 2026

Information

Country: US
Address: —
Website: resolvesurg.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(906)226-9909
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 117560455

Catalogue (1081)

Page 2 of 22

Device	Model / Reference	Registries	Class	Status
C-Plus PEEK IBF System	724-072	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-1855-15-6C	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-A-TRIAL-22-9	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-1450-15	FDA UDI	Class II	Active
MIS FUSION Instruments	724-927	FDA UDI	Class I	Active
Synergent™ DBM with CCC, 10cc	004940	FDA UDI	Class II	Active
RTI Allograft Paste	802203	FDA UDI	Class II	Active
MIS FUSION Instruments	724-604	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-1455-9-6L	FDA UDI	Class II	Active
Precision Allograft Cartilage Kit (PACK™)	PAC-A2020	FDA UDI	Class I	Active
Quantum Spinal Fixation System	724-853	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-SLIDER-22-50	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-A-TRL-26-17-6LL	FDA UDI	Class I	Active
Fusion Lateral Instrument Set	723-251	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-2245-15-6L	FDA UDI	Class II	Active
MaxFuse PEEK VBR SYSTEM	724-430	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-1855-9	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-A-TRIAL-26-17	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	10-55-PR-115	FDA UDI	Class II	Unknown
Quantum Spinal Fixation System	721-941	FDA UDI	Class I	Active
Clarity Retractor System	724-520	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-1860-9-6C	FDA UDI	Class II	Active
BioSet®	807820	FDA UDI	Class II	Active
Precision Allograft Cartilage Kit (PACK™)	PAC-A2524	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-A-TRIAL-26-9	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-1445-11	FDA UDI	Class II	Active
C-Plus PEEK IBF System	724-726	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-A-TRIAL-26-15	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-2650-15-12L	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-1865-13-6C	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-A-TRL-18-15-6LR	FDA UDI	Class I	Active
Fusion Lateral Instrument Set	724-362	FDA UDI	Class I	Active
C-Plus PEEK IBF System	724-748	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-1865-17-12L	FDA UDI	Class II	Active
Fusion Lateral Instrument Set	723-551	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-1865-9-6L	FDA UDI	Class II	Active
RegenaVate™ Formable DBM, 1cm x 4cm x 0.5cm, 2cc	ZR0302	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-1840-15-18L	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-2665-9-6L	FDA UDI	Class II	Active
BioSet®	007875	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-1840-7-6C	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-1855-15-12L	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-TRIAL-26-9-6L	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-1435-15	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-A-TRL-22-15-6LL	FDA UDI	Class I	Active
C-Plus PEEK IBF System	724-318	FDA UDI	Class I	Active
Clarity Retractor System	724-028	FDA UDI	Class I	Active
BioSet®	006805	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-2255-15-6L	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	10-55-RH-600	FDA UDI	Class II	Unknown

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 23, 2017	Z-1441-2017	—	terminated	Incorrect instructions for use (IFU) included.
Dec 6, 2013	Z-0939-2014	—	terminated	RTI Surgical, Inc. of Alachua, FL is recalling their OPTEFORM Allograft Paste, 5cc as it may contain a 10 cc fluid dispenser. The 10cc fluid dispenser does not include the correct fluid fill line reference for reconstitution of 5cc past allografts.
Oct 7, 2013	Z-0627-2014	—	terminated	As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requirement for labeling as a partial Vertebral Body Replacement Device (VBR). While the use of this device as a partial VBR is unlikely due to the size of the device, use of this device as a partial VBR could result in a s