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INTERVENTIONAL SPINE, INC

Last updated May 24, 2026

What INTERVENTIONAL SPINE, INC makes

The company manufactures orthopaedic spinal fixation devices, including internal fixation systems, bone screws, and metallic spinal interbody and fusion cages designed for surgical spinal stabilization. Their portfolio also includes reusable surgical tools such as rotary handpieces, implant drivers, and procedure kits, as well as bone-nailing compression screws and drill bits for spinal procedures. Expandable interbody implants and compression devices are among the specialized products used in spinal fusion surgeries.

These devices are regulated under the FDA’s classification system, with products falling into Class I, Class II, and Unclassified (U) categories. They are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries, ensuring compliance with U.S. medical device regulations. The company operates within the United States, adhering to domestic regulatory requirements for spinal orthopaedic hardware.

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

Frequently asked questions

What types of medical devices does Interventional Spine, Inc. manufacture?

Interventional Spine, Inc. specializes in orthopaedic spinal fixation devices. Their portfolio includes internal orthopaedic fixation system implantation kits, bone screws for spinal stabilization, metallic spinal interbody and fusion cages, and reusable surgical tools like rotary handpieces and implant drivers. They also produce specialized items such as expandable interbody implants, compression screws, and drill bits, all designed for spinal stabilization and fusion surgeries.

Where is Interventional Spine, Inc. based, and how does that affect its regulatory compliance?

Interventional Spine, Inc. is based in the United States, which means its devices are subject to U.S. regulatory requirements, specifically those governed by the FDA. Since the company’s products fall under Class I, Class II, and Unclassified (U) categories, they must comply with FDA regulations applicable to those classifications, including premarket submissions like 510(k) clearances for Class II devices.

Which regulatory registries list Interventional Spine, Inc.’s devices?

Interventional Spine, Inc.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) registry documents premarket submissions for Class II devices, while the UDI system ensures standardized identification and traceability of medical devices in the U.S., helping track compliance and post-market surveillance.

How are Interventional Spine, Inc.’s devices classified under FDA regulations?

Interventional Spine, Inc.’s devices are classified under three FDA categories: Class I (generally low-risk devices with minimal regulation), Class II (moderate-risk devices requiring special controls like 510(k) clearance), and Unclassified (U) devices, which may require additional evaluation depending on their risk profile. Classification determines the regulatory pathway, with higher-risk devices requiring more stringent premarket review.

What kinds of spinal fixation solutions does Interventional Spine, Inc. provide, and how do they differ?

The company offers a range of spinal fixation solutions, including permanent implants like metallic interbody and fusion cages (used for structural support in fusion surgeries), bone screws for internal fixation, and reusable surgical tools like rotary handpieces and drivers. Expandable interbody implants, such as the Opticage, provide adjustable spacing during surgery, while compression devices like the BONE-LOK MVP stabilize bone fragments. These vary in function—some are implants for long-term support, while others are tools for surgical precision.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: i-spineinc.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 800-497-0484
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 017663522

Catalogue (303)

Page 5 of 7

Device	Model / Reference	Registries	Class	Status
LS .062 K-Wire	6072-00	FDA UDI	Class I	Unknown
7.3mm Easy Out Extractor	6055	FDA UDI	Class I	Active
PERPOS FCD-2 System	9062	FDA UDI	U	Active
Opticage Expandable Interbody Implant	9070-14	FDA UDI	Class II	Active
Pin Driver, Blue	6161-01	FDA UDI	Class I	Unknown
Compression Gun	6036	FDA UDI	Class I	Active
Opticage Expandable Interbody Implant	9070-10	FDA UDI	Class II	Active
Opticage Expandable Interbody Implant	9180-01	FDA UDI	Class II	Unknown
.062" x 6" Stylet	6032	FDA UDI	Class I	Active
BONE-LOK MVP Cortical-Cancellous Compression Device	TMCD-45-5060S	FDA UDI	Class II	Active
Pin Driver, Lavender	6161-02	FDA UDI	Class I	Unknown
Cohen Drill	6138-00	FDA UDI	Class I	Unknown
Opticage Expandable Interbody Implant	9180-05	FDA UDI	Class II	Unknown
1/4" Quicklock Adapter	6053	FDA UDI	Class I	Active
4.5mm Cortex Drill	6026	FDA UDI	Class I	Active
3.0mm Cortex Drill	6011	FDA UDI	Class I	Active
3.5/4.5mm Compression Tool	6027	FDA UDI	Class I	Active
3.5/4.5mm Non-Cannulated Driver	6029	FDA UDI	Class I	Active
7.3mm Short Cortex Drill Stop	6062	FDA UDI	Class I	Active
4.5mm BONE-LOK PLS Implant	LSW-45-3040	FDA UDI	U	Unknown
7.3mm BONE-LOK Implant	TLCD-73-7080S32	FDA UDI	Class II	Active
Access Needle	6949	FDA UDI	Class I	Unknown
8 Degree Lordotic, Opticage Expandable Interbody Implant	9101-12	FDA UDI	Class II	Unknown
Tether	6201-00	FDA UDI	Class I	Unknown
7.3mm BONE-LOK Implant	TLCD-73-100110S32	FDA UDI	Class II	Active
Opticage Expandable Interbody Implant	9080-10	FDA UDI	Class II	Active
Opticage Expandable Interbody Implant	9080-06	FDA UDI	Class II	Active
PerX360 System, Implant Caddy	6208-00	FDA UDI	Class I	Unknown
3.0mm Compression Tool	6014	FDA UDI	Class I	Active
8 Degree Lordotic, Opticage Expandable Interbody Implant	9101-19	FDA UDI	Class II	Unknown
MVP Instrument Tray Assembly	6020	FDA UDI	Class I	Active
Suction Tube Assembly	6194-00	FDA UDI	Class I	Unknown
Opticage Expandable Interbody Implant	9180-02	FDA UDI	Class II	Unknown
PERPOS PLS SYSTEM, Single Implant	9045-01	FDA UDI	U	Unknown
Distractor Shaver, 5x14mm	6192-08	FDA UDI	Class I	Unknown
3.5/4.5mm Depth Gauge	6030	FDA UDI	Class I	Active
Opticage Expandable Interbody Implant	9180-20	FDA UDI	Class II	Unknown
BONE-LOK MVP Cortical-Cancellous Compression Device	SMCD-45-6070S	FDA UDI	Class II	Active
G3 Insertion Instrument	6215-00	FDA UDI	Class I	Unknown
Parallel Wire Guide	6048	FDA UDI	Class I	Active
Opticage Expandable Interbody Implant	9080-04	FDA UDI	Class II	Active
8 Degree Lordotic, Opticage Expandable Interbody Implant	9101-18	FDA UDI	Class II	Unknown
7.3mm Depth Gauge	6042	FDA UDI	Class I	Active
Flexible Driver	6101-00	FDA UDI	Class I	Active
PERPOS FCD-2 Removal Kit	9067	FDA UDI	Class I	Active
SLX System Compression Tool	6005	FDA UDI	Class I	Active
Opticage Expandable Interbody Implant	9080-07	FDA UDI	Class II	Active
BONE-LOK MVP Cortical-Cancellous Compression Device	SMCD-35-1520S	FDA UDI	Class II	Active
.035" K-Wire Threaded Tip	6010	FDA UDI	Class I	Active
G3 Driver Assembly	6216-00	FDA UDI	Class I	Active

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FDA Recalls (10)

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

Interventional Spine, Inc. has ten recall records initiated between February 22, 2008, and November 22, 2016, all marked as terminated. The recalls involved issues with device components, including drivers potentially containing burrs, K-wires with incorrect tip diameters, separation risks during implantation, disengaging pull pins, and drill breakage during use. Each recall cited specific mechanical or functional defects that could affect procedural performance or device functionality.

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
Nov 22, 2016	Z-0941-2017	—	terminated	During implantation, the proximal end of the device could separate if the angle between the device and insertion instrument is too steep. This separation will prevent the device from expanding.
Mar 23, 2011	Z-2719-2011	—	terminated	This recall has been initiated due to K-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw. Removing the K-wire during a procedure may dislocate the implant resulting in the implant loosening or being pulled out or position. Use of this product may result in a delay of the surgical procedure and/or pull-out of the facet screw
Mar 23, 2011	Z-2718-2011	—	terminated	This recall has been initiated due to K-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw. Removing the K-wire during a procedure may dislocate the implant resulting in the implant loosening or being pulled out or position. Use of this product may result in a delay of the surgical procedure and/or pull-out of the facet screw
Mar 15, 2011	Z-3033-2011	—	terminated	This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed with a device driver rather than the compression tool. Use of this product may result in less than optimal compression leading to pseudoarthrosis, non-union or facet pain.
Mar 15, 2011	Z-3034-2011	—	terminated	This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed with a device driver rather than the compression tool. Use of this product may result in less than optimal compression leading to pseudoarthrosis, non-union or facet pain.
Feb 3, 2011	Z-0046-2012	—	terminated	This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw, resulting in difficulty screwing the facet screw into the bone. Use of this product may result in a delay of the surgical procedure
Feb 3, 2011	Z-0047-2012	—	terminated	This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw, resulting in difficulty screwing the facet screw into the bone. Use of this product may result in a delay of the surgical procedure
Feb 3, 2011	Z-0045-2012	—	terminated	This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw, resulting in difficulty screwing the facet screw into the bone. Use of this product may result in a delay of the surgical procedure
Feb 22, 2008	Z-0420-2012	—	terminated	The recall was intiated because Interventional Spine has confirmed that the PERPOS 2-in-1 Drill (6070) manufactured by a contract manufacturer for Interventional Spine, Inc., may break during use.
Feb 22, 2008	Z-0419-2012	—	terminated	The recall was intiated because Interventional Spine has confirmed that the PERPOS 2-in-1 Drill (6070) manufactured by a contract manufacturer for Interventional Spine, Inc., may break during use.