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Rti Surgical, Inc.

Last updated May 24, 2026

What Rti Surgical, Inc. makes

RTI Surgical, Inc. manufactures spinal interbody fusion cages made from polymeric materials, orthopaedic fixation systems and associated surgical kits, reusable implant templates, and human-derived bone matrix implants. Their portfolio includes orthopaedic tools such as reusable inserters, trial-implant holders, bone curettes, and power tool attachments for drilling. They also supply meniscus allografts for transplantation and lateral plate systems for spinal or joint stabilization.

The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Their products are regulated under U.S. medical device laws, with specific authorisation requirements depending on the device class. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

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 8 of 22

Device	Model / Reference	Registries	Class	Status
Cross-Fuse® II PEEK IBF System	38-2255-11-6L	FDA UDI	Class II	Active
Synergent™ DBM, 10cc	004910	FDA UDI	Class II	Active
Cross-Fuse II PEEK IBF System	724-516	FDA UDI	Class I	Active
Bullet-Tip Peek Ibf System	720-238	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	10-55-PR-140	FDA UDI	Class II	Unknown
Cross-Fuse® II PEEK IBF System	38-1850-17-6C	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-2670-15-6L	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-2260-11-12L	FDA UDI	Class II	Active
Contact PEEK IBF System	723-352	FDA UDI	Class I	Unknown
Cross-Fuse® II PEEK IBF System	38-1860-13	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-1855-13-12L	FDA UDI	Class II	Active
Fusion Lateral Instrument Set	724-452	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-INSERTER-HL	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-1845-11-12L	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-TRIAL-26-7	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-2250-15-12L	FDA UDI	Class II	Active
Precision Allograft Cartilage Kit (PACK™)	PAC-A1712	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-1840-7	FDA UDI	Class II	Active
RTI Allograft Paste	812201	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-A-TRL-18-13-6LL	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-1455-9-12L	FDA UDI	Class II	Active
BioSet®	806710	FDA UDI	Class II	Active
Precision Allograft Cartilage Kit (PACK™)	PAC-A2532	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-1450-15-6L	FDA UDI	Class II	Active
C-Plus PEEK IBF System	723-633	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	10-55-PR-125	FDA UDI	Class II	Unknown
Cross-Fuse® II PEEK IBF System	38-2270-17-6L	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-TRIAL-22-15-18L	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-1845-13-12L	FDA UDI	Class II	Active
MaxFuse PEEK VBR SYSTEM	724-831	FDA UDI	Class I	Active
Fortilink-TS IBFSystem	725-168	FDA UDI	Class I	Active
MIS FUSION Instruments	724-601	FDA UDI	Class I	Active
C-Plus PEEK IBF System	724-710	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-A-INSERTER-26	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-1860-9-6L	FDA UDI	Class II	Active
Meniscus Allograft Transplantation (MAT)	999001	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-2655-9	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-1870-11-6L	FDA UDI	Class II	Active
C-Plus PEEK IBF System	724-063	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-INSERTER-14	FDA UDI	Class I	Active
MIS FUSION Instruments	723-389	FDA UDI	Class I	Active
C-Plus PEEK IBF System	724-071	FDA UDI	Class I	Active
AlloWedge	55-DISTRACTOR	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-1450-13-6L	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	10-55-PR-80	FDA UDI	Class II	Unknown
Precision Allograft Cartilage Kit (PACK™)	PAC-A0112	FDA UDI	Class I	Active
MIS FUSION Instruments	724-231	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	01-PA-675-100	FDA UDI	Class II	Unknown
Cross-Fuse® II PEEK IBF System	38-2655-13-12L	FDA UDI	Class II	Active
MaxFuse PEEK VBR SYSTEM	724-431	FDA UDI	Class I	Active

Related Companies

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Authorities

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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.

RTI Surgical, Inc. has three recall records initiated between October 7, 2013, and January 23, 2017, all of which are recorded as terminated. The recalls involved documentation errors for the 10 mm x 12 mm Webless C-Plus implants, a potential mislabeling of the OPTEFORM Allograft Paste 5cc packaging (including an incorrect fluid fill line), and incorrect instructions for use for an unspecified product.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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