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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)

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Device	Model / Reference	Registries	Class	Status
7.3mm Bone-Lok Washer	2057-00	FDA UDI	Class II	Active
Opticage Expandable Interbody Implant	9070-00	FDA UDI	Class II	Active
8 Degree Lordotic, Opticage Expandable Interbody Implant	9101-15	FDA UDI	Class II	Unknown
T-Handle, Non-Ratcheting	6197-00	FDA UDI	Class I	Unknown
Opticage Expandable Interbody Implant	9080-19	FDA UDI	Class II	Active
Opticage Expandable Interbody Implant	9180-16	FDA UDI	Class II	Unknown
11mm TELEPORT Tissue Retractor, Reusable	6086-01	FDA UDI	Class I	Unknown
7.3mm BONE-LOK Implant	TLCD-73-100110S	FDA UDI	Class II	Active
Opticage Expandable Interbody Implant	9180-07	FDA UDI	Class II	Unknown
Opticage Expandable Interbody Implant	9080-22	FDA UDI	Class II	Active
6.5mm Reamer	6195-00	FDA UDI	Class I	Unknown
Graft Delivery Assembly	6184-00	FDA UDI	Class I	Unknown
Quick Release Handle	6079	FDA UDI	Class I	Unknown
3.2mm Wire Sleeve	6052	FDA UDI	Class I	Active
Opticage Expandable Interbody Implant	9180-12	FDA UDI	Class II	Unknown
8 Degree Lordotic, Opticage Expandable Interbody Implant	9101-03	FDA UDI	Class II	Unknown
Opticage Expandable Interbody Implant	9180-06	FDA UDI	Class II	Unknown
Opticage Expandable Interbody Implant	9070-07	FDA UDI	Class II	Active
Opticage Expandable Interbody Implant	9070-12	FDA UDI	Class II	Active
3.8 CS Flexible Tap	6119	FDA UDI	Class I	Unknown
Stage 1 Distractor	6205-00	FDA UDI	Class I	Unknown
SLX Instrument Tray Assembly	6016	FDA UDI	Class I	Active
Opticage Expandable Interbody Implant	9070-03	FDA UDI	Class II	Active
PERPOS PLS Instruments with Tray	9039-02	FDA UDI	Class I	Unknown
Mallet	6199-00	FDA UDI	Class I	Unknown
Quick Connect Handle	6017	FDA UDI	Class I	Unknown
Distractor Shaver, 5x13mm	6192-07	FDA UDI	Class I	Unknown
.045" x 6" K-Wire	6021	FDA UDI	Class I	Active
8 Degree Lordotic, Opticage Expandable Interbody Implant	9101-17	FDA UDI	Class II	Unknown
Optiport, 11.5mm I.D.	6173-00	FDA UDI	Class I	Unknown
PDS Driver	6094	FDA UDI	Class I	Active
Distractor Shaver, 5x11mm	6192-05	FDA UDI	Class I	Unknown
Opticage Expandable Interbody Implant	9180-19	FDA UDI	Class II	Unknown
1.9mm Driver	6013	FDA UDI	Class I	Active
PERPOS PLS SYSTEM, Dual Implant	9045-02	FDA UDI	U	Unknown
7.3mm BONE-LOK Implant	TLCD-73-90100S32	FDA UDI	Class II	Active
Distractor Shaver, 5x12mm	6192-06	FDA UDI	Class I	Unknown
Slap Hammer	6120	FDA UDI	Class I	Active
3.0mm Depth Gauge	6012	FDA UDI	Class I	Active
Opticage Expandable Interbody Implant	9180-03	FDA UDI	Class II	Active
8 Degree Lordotic, Opticage Expandable Interbody Implant	9101-09	FDA UDI	Class II	Unknown
3.8 CS Curved Sheath Assembly	6088-00	FDA UDI	Class I	Unknown
Opticage Expandable Interbody Implant	9080-08	FDA UDI	Class II	Active
2.7mm Go-No Go Gauge	6006	FDA UDI	Class I	Active
Opticage Expandable Interbody Implant	9070-23	FDA UDI	Class II	Active
Opticage Expandable Interbody Fusion Device	K152156	FDA 510(k)	Class II	Active
Single Use Perpos Pls System, 4.5 Bone-Lok Pls Implant	K082795	FDA 510(k)	U	Active
Opticage Interbody Fusion Device, Model 9080-00	K132479	FDA 510(k)	Class II	Active
Opticage(R) Expandable Interbody Fusion Device	K160464	FDA 510(k)	Class II	Active
Opticage Interbody Fusion Device, Model Series 9070	K133583	FDA 510(k)	Class II	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.