(79 days)
Not Found
No
The description focuses on the mechanical components and materials of a spinal implant, with no mention of AI or ML capabilities.
Yes
The device is a vertebral body replacement system used to treat damaged or unstable vertebrae due to tumor or trauma, aiming to restore stability and function.
No
The device is described as a vertebral body replacement device and an implant, used to replace damaged or unstable vertebral bodies. Its function is treatment, not diagnosis.
No
The device description explicitly states it consists of physical components made of titanium alloy, such as cylinders, endplates, and set screws. It is a physical implant, not software.
Based on the provided information, the VERTE-SPAN™ Spinal System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a vertebral body replacement device for use in the thoracolumbar spine due to tumor or trauma. This is a surgical implant used directly within the body.
- Device Description: The description details the physical components of the implant (titanium cylinders, endplates, set screws) and its material. This is consistent with a medical device intended for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. The VERTE-SPAN™ Spinal System is a therapeutic device implanted inside the body to provide structural support.
N/A
Intended Use / Indications for Use
The VERTE-SPAN™ Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-SPAN™ Spinal System is to be used with supplemental fixation. Specifically, the VERTE-SPAN™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, Titanium DYNALOK™ CLASSIC Spinal System, LAURAIN DEWALD Anterior Fixation System, Titanium TSRH® Spinal System, Titanium CD HORIZON® Spinal System or the Titanium GDLH® Spinal System. Additionally, the VERTE-SPAN™ device is intended to be used with bone graft.
Product codes
MOP, KWO, MQP
Device Description
The VERTE-SPAN™ device consists of titanium cylinders of various lengths and diameters, endplates and break-off set screws. The assembled VERTE-SPAN™ device consists of five components (one hollow metal cylinder, two endplates and two set screws). The VERTE-SPAN™ components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The VERTE-SPAN™ Spinal System implant components are made of medical grade titanium alloy (Ti-6A1-4V) described by ASTM Standard F136 or ISO 5832-3.
The purpose of this submission is to add components to the existing system and to incorporate some minor design changes.
The VERTE-SPAN™ Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
VERTE-SPAN™ Spinal System 510(k) Summary December 2002
FEB 2 6 2003
- I. Company: Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
II. Proprietary Trade Name: VERTE-SPAN™ Spinal System Regulation Number: 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Product code: MOP, KWO
Product Description III.
The VERTE-SPAN™ device consists of titanium cylinders of various lengths and diameters, endplates and break-off set screws. The assembled VERTE-SPAN™ device consists of five components (one hollow metal cylinder, two endplates and two set screws). The VERTE-SPAN™ components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The VERTE-SPAN™ Spinal System implant components are made of medical grade titanium alloy (Ti-6A1-4V) described by ASTM Standard F136 or ISO 5832-3.
The purpose of this submission is to add components to the existing system and to incorporate some minor design changes.
The VERTE-SPAN™ Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability
IV. Indications
The VERTE-SPAN" Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-SPAN™ Spinal System is to be used with supplemental fixation. Specifically, the VERTE-SPAN™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, Titanium DYNALOK™ CLASSIC Spinal System, LAURAIN DEWALD Anterior Fixation System, Titanium TSRH® Spinal System, Titanium CD HORIZON® Spinal System or the Titanium GDLH® Spinal System. Additionally, the VERTE-SPANTM device is intended to be used with bone graft.
V. Substantial Equivalence
Documentation was provided which demonstrated the VERTE-SPAN™ Spinal System to be substantially equivalent itself the VERTE-SPAN™ Spinal System K010930 (SE 10/24/01).
. 6329
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Public Health Service
FEB 2 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Richard Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
K024049 Re:
Trade Name: VERTE-SPAN™ Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: January 30, 2003 Received: January 31, 2003
Dear Dr. Treharne:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general conirols provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Dr. Richard Treharne, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
L. Mark N. Milkman
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
December 2002
KO24049 510(k) Number (if known):
Device Name: VERTE-SPAN™ Spinal System
Indications for Use:
The VERTE-SPANTM Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-SPAN™ Spinal System is to be used with supplemental fixation. Specifically, the VERTE-SPAN™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, Titanium DYNALOK™ CLASSIC Spinal System, LAURAIN DEWALD Anterior Fixation System, Titanium TSRH® Spinal System, Titanium CD HORIZON® Spinal System or the Titanium GDLH® Spinal System. Additionally, the VERTE-SPAN™ device is intended to be used with bone graft.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional 1-2-96)
Mark N Milhem
estorative ()(k) Number
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