Question 1

What types of medical devices does Spinal Resources Inc manufacture?

Accepted Answer

Spinal Resources Inc specializes in spinal fixation hardware, primarily focusing on non-bioabsorbable orthopaedic devices. Their product line includes pedicle screws, set screws, bone-screw system connectors, orthopaedic bone pins, surgical screwdrivers (reusable), bone wires, and surgical instrument racks. These devices are designed for internal spinal stabilization and orthopaedic procedures, such as securing spinal segments during surgery.

Question 2

Where is Spinal Resources Inc based, and where are their devices intended for use?

Accepted Answer

Spinal Resources Inc is based in the United States. Their devices are manufactured and intended for use within the U.S. market, where they must comply with applicable FDA regulations for spinal and orthopaedic fixation systems.

Question 3

Which regulatory registries or databases list Spinal Resources Inc’s devices?

Accepted Answer

Spinal Resources Inc’s devices are recorded in the FDA’s Unique Device Identifier (UDI) database. This registry tracks Class II devices, which include all of their listed products, ensuring traceability and compliance with U.S. regulatory requirements.

Question 4

How are Spinal Resources Inc’s devices classified under FDA regulations?

Accepted Answer

All of Spinal Resources Inc’s devices fall under FDA Class II classification. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness, such as spinal fixation hardware, which requires validation of performance and manufacturing controls.

Question 5

What is an example of a key product offered by Spinal Resources Inc?

Accepted Answer

A key product offered by Spinal Resources Inc is the Swedge Pedicle Screw Fixation System. This system is designed for securing spinal segments during surgical interventions, providing internal stabilization for spinal procedures. It exemplifies their focus on non-bioabsorbable spinal fixation hardware.

Device	Model / Reference	Registries	Class	Status
Swedge Pedicle Screw Fixation System	RM5TC47555-500	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	SPSST85-70	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	2-142	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	2-139-01	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	RSCT55-50	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	RSTT47555-130	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	SPSST65-40	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	SPSST75-45	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	2-105-45	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	SRI1026	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	RSTT47555-150	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	2-109-65	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	2-106-65	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	2-109-55	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	SPSST85-100	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	LC-04	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	RM5TC47560-500	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	SPSCT8555	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	2-137	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	2-105-75	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	RSST55-400	FDA UDI	Class II	Active
S-Wire	NSTS16-500	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	2-150	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	RM4CC47555-450	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	SRI1001	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	SPSST75-50	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	2-125	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	RSCTT47555-120	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	RSST55-60	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	PSST65-45	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	RSTT47555-250	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	RSCT55-55	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	SPSST65-45	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	SPSST55-45	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	RSST55-110	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	RSST55-75	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	RSST55-130	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	RSST55-70	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	SPSST45-50	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	RSTT47555-350	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	RSCTT47555-130	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	RM3CC47560-400	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	RSST55-90	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	SPSST55-65	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	SPSST85-110	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	RSTT47555-450	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	RM1CC47560-300	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	RSST55-220	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	SPSST65-30	FDA UDI	Class II	Active
Swedge Pedicle Screw Fixation System	2-106-55	FDA UDI	Class II	Active

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