(218 days)
Not Found
No
The description focuses on the mechanical components and materials of a cervical plate system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is an implantable surgical system for spinal fixation, not a therapeutic device that directly treats a condition through non-invasive means or active intervention. Its purpose is to provide mechanical stabilization to the cervical spine.
No
This device is an anterior cervical plate system intended for surgical fixation to the cervical spine, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of titanium alloy, such as plates, screws, sub-plates, and rivets, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The Maxima™ Anterior Cervical Plate System is a physical implantable device made of titanium alloy. It is surgically placed in the cervical spine.
- Intended Use: The intended use is for anterior fixation to the cervical spine to treat various conditions. This is a surgical intervention, not a diagnostic test performed on a specimen.
The description clearly indicates a surgical implant used for structural support and fixation within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Maxima™ Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
Maxima™ Anterior Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, sub-plate, rivets and the associated instruments. The sub-plate is pre-assembled to the main plate and designed to prevent screws from backing out using the elastic behavior during the screw insertion. The rivets are also pre-assembled to the main plate and designed to assemble the sub-plate to the main plate firmly. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. Screws can be inserted in the center hole of Main Plate - S type. Main Plate - S type are offered in no hole, one hole, two hole, three hole and ranges from 24mm to 108mm. Screws are available in lengths from 10mm to 20mm in 1mm increments. The screws have either a 3,5mm or 4.0mm diameter. Variable screw and Semi-fixed screw are provided. Variable screw provides more rotational and translational degree of freedom than Semi-Fixed screws. The Maxima™ Anterior Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
Anterior cervical spine
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)
Mechanical testing was carried out according to ASTM F1717-01 to validate the Maxima" Anterior Cervical Plate System. The testing demonstrated substantially equivalent to the ZEPHIR™ Anterior Cervical Plate System (K994239, K030327) in terms of intended use, materials, and anatomical sites.
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
K061002 510(k) SUMMARY
NOW 15 2006
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
| Submission Information: | |
|---|---|
| Contact: | Betty Lim |
| Regulatory Affairs | |
| Sponsor: | U&i Corporation |
| YongHyun-Dong 529-1, Euijungbu | |
| Kyonggi-Do, Korea 480-050 | |
| Phone: 82-31-852-0102(ext. 302) | |
| Fax: 82-31-852-0107 | |
| E-mail: willerry@lycos.co.kr | |
| Date Prepared: | Mar. 14, 2006 |
| Device Identification | |
| Trade Name: | Maxima™ Anterior Cervical Plate System |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis (KWQ) |
Substantially Equivalent Predicate Legally Marketed Devices
The subject Maxima™ Anterior Cervical Plate System is substantially equivalent in intended use, materials, anatomical site to ZEPHIR™ Anterior Cervical Plate System (K994239, K030327)
1
Device Description
Maxima™ Anterior Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, sub-plate, rivets and the associated instruments. The sub-plate is pre-assembled to the main plate and designed to prevent screws from backing out using the elastic behavior during the screw insertion. The rivets are also pre-assembled to the main plate and designed to assemble the sub-plate to the main plate firmly. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. Screws can be inserted in the center hole of Main Plate - S type. Main Plate - S type are offered in no hole, one hole, two hole, three hole and ranges from 24mm to 108mm. Screws are available in lengths from 10mm to 20mm in 1mm increments. The screws have either a 3,5mm or 4.0mm diameter. Variable screw and Semi-fixed screw are provided. Variable screw provides more rotational and translational degree of freedom than Semi-Fixed screws.
The Maxima™ Anterior Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.
Indications for Use:
The Maxima™ Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include:
degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Statement of Technological Comparison:
Mechanical testing was carried out according to ASTM F1717-01 to validate the Maxima" Anterior Cervical Plate System. The testing demonstrated substantially equivalent to the ZEPHIR™ Anterior Cervical Plate System (K994239, K030327) in terms of intended use, materials, and anatomical sites.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, on the right side. To the left of the caduceus is a circular inscription that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
U&I Corporation c/o Mr. D. K. Rah 529-1 YongHyun-Dong Euijungbu, Kyonggi-Do, Korea 480-050
NOV 15 2006
Re: K061002
Trade Name: Maxima™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: K WQ Dated: October 23, 2006 Received: October 25, 2006
Dear Mr. Rah:
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 controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, l'isting of devices, good manufacturing practice, labeling, and prohibitions against mishranding 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, TDA 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 seconic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050.
3
Page 2 - Mr. D. K. Rah
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. Young ust 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 storonic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050.
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, permitte 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 (240) 276-0120. Also, please note the regulation one it led, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may ohtain other general information on your responsibilities under the Act from the Division of Sonall Manufacturers, International and Consumer Assistance at its toll-free number (800) 633-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS for USE STATEMENT
510(k) Number (if known): K061002
Device Name: Maxima™ Anterior Cervical Plate System.
Indications for Use: The Maxima™ Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include:
degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Prescription Use X (Per 21 CFR 801 Subpart D)
OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Of Division of General, Restorative and Neurological Devices
510(k) Number K061062