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Rti Surgical, Inc.

US

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
—
LinkedIn
—
Facebook
—
Phone
+1(906)226-9909
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
117560455

Catalogue (1081)

Page 11 of 22
DeviceModel / ReferenceRegistriesClassStatus
Cross-Fuse® II PEEK IBF System 38-2660-15-12L
FDA UDI
Class IIActive
Streamline TL Spinal Fixation System 10-55-PR-70
FDA UDI
Class IIUnknown
Cross-Fuse® II PEEK IBF System 38-1855-9-6L
FDA UDI
Class IIActive
MIS FUSION Instruments 724-606
FDA UDI
Class IActive
Precision Allograft Cartilage Kit (PACK™) PAC-A1116
FDA UDI
Class IActive
Cross-Fuse® II PEEK IBF System 38-2670-17
FDA UDI
Class IIActive
Cross-Fuse® II PEEK IBF System 38-1870-15-6L
FDA UDI
Class IIActive
Cross-Fuse® II PEEK IBF System 38-2670-11
FDA UDI
Class IIActive
Streamline TL Spinal Fixation System 01-PA-675-75
FDA UDI
Class IIUnknown
Cross-Fuse® II PEEK IBF System 38-1445-13-6L
FDA UDI
Class IIActive
Cross-Fuse® II PEEK IBF System 38-2255-17-6L
FDA UDI
Class IIActive
Precision Allograft Cartilage Kit (PACK™) PAC-A2200
FDA UDI
Class IActive
Cross-Fuse® II PEEK IBF System 38-L45INST-1822
FDA UDI
Class IActive
Cross-Fuse® II PEEK IBF System 38-1455-13-6L
FDA UDI
Class IIActive
Streamline TL Spinal Fixation System 01-PA-775-75
FDA UDI
Class IIUnknown
MIS FUSION Instruments 724-951
FDA UDI
Class IActive
Cross-Fuse® II PEEK IBF System 38-2670-17-6L
FDA UDI
Class IIActive
MaxFuse PEEK VBR SYSTEM 724-843
FDA UDI
Class IActive
Cross-Fuse® II PEEK IBF System 38-2250-11-6L
FDA UDI
Class IIActive
AlloWedge 55-C-22-16-7
FDA UDI
Class IIActive
C-Plus PEEK IBF System 724-709
FDA UDI
Class IActive
Cross-Fuse® II PEEK IBF System 38-1845-11-6C
FDA UDI
Class IIActive
Cross-Fuse® II PEEK IBF System 38-1440-9-6L
FDA UDI
Class IIActive
Precision Allograft Cartilage Kit (PACK™) PAC-A2520
FDA UDI
Class IActive
Cross-Fuse® II PEEK IBF System 38-2650-9
FDA UDI
Class IIActive
C-Plus PEEK IBF System 724-082
FDA UDI
Class IActive
Quantum Spinal Fixation System 723-273
FDA UDI
Class IActive
Precision Allograft Cartilage Kit (PACK™) PAC-A1734
FDA UDI
Class IActive
Cross-Fuse® II PEEK IBF System 38-2670-11-12L
FDA UDI
Class IIActive
Cross-Fuse® II PEEK IBF System 38-A-TRL-14-11-6LR
FDA UDI
Class IActive
Cross-Fuse® II PEEK IBF System 38-2655-11-12L
FDA UDI
Class IIActive
Cross-Fuse® II PEEK IBF System 38-1435-11-6C
FDA UDI
Class IIActive
Cross-Fuse® II PEEK IBF System 38-A-TRL-26-9-6LR
FDA UDI
Class IActive
Cross-Fuse® II PEEK IBF System 38-2255-9-6L
FDA UDI
Class IIActive
Cross-Fuse® II PEEK IBF System 38-TRIAL-26-17
FDA UDI
Class IActive
Fusion Posterior Instrument Set 723-410
FDA UDI
Class IActive
C-Plus PEEK IBF System 724-066
FDA UDI
Class IActive
MaxFuse PEEK VBR SYSTEM 724-841
FDA UDI
Class IActive
Cross-Fuse® II PEEK IBF System 38-2645-13
FDA UDI
Class IIActive
Cross-Fuse® II PEEK IBF System 38-1850-11-6C
FDA UDI
Class IIActive
Cross-Fuse® II PEEK IBF System 38-1865-9
FDA UDI
Class IIActive
C-Plus PEEK IBF System 724-317
FDA UDI
Class IActive
Cross-Fuse® II PEEK IBF System 38-1845-7-6C
FDA UDI
Class IIActive
Cross-Fuse® II PEEK IBF System 38-A-TRL-22-17-6LL
FDA UDI
Class IActive
Cross-Fuse® II PEEK IBF System 38-1445-13
FDA UDI
Class IIActive
MaxFuse PEEK VBR SYSTEM 724-846
FDA UDI
Class IActive
Cross-Fuse® II PEEK IBF System 38-2655-11-6L
FDA UDI
Class IIActive
Cross-Fuse® II PEEK IBF System 38-1850-9-12L
FDA UDI
Class IIActive
C-Plus PEEK IBF System 724-074
FDA UDI
Class IActive
Precision Allograft Cartilage Kit (PACK™) PAC-A2012
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

DateRecall No.ClassStatusReason
Jan 23, 2017Z-1441-2017—terminated

Incorrect instructions for use (IFU) included.

Dec 6, 2013Z-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, 2013Z-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