(210 days)
When used as a pedicle screw fixation system in the non-cervical spine of skeletally mature patients, the Procyon Spinal System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: 1) degenerative spondylolisthesis with objective evidence of neurological impairment, 2) fracture, 3) dislocation, 4) scoliosis, 5) kyphosis, 6) spinal tumor and 7) failed previous fusion (pseudoarthrosis).
In addition, when used as a pedicle screw fixation system, the Procyon Spinal System is intended for skeletally mature patients: 1) having severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, 2) who are receiving fusion by autogenous bone graft only; 3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and 4) who are having the device removed after the development of a solid fusion mass.
The Procyon Spinal System consists of polyaxial screws, rods, and connecting components. The components are fabricated from titanium alloy (ASTM F-136).
This is a premarket notification for the Procyon Spinal System, a medical device, not an AI/ML device, and therefore does not contain information related to acceptance criteria, diagnostic performance, or studies with methodologies relevant to AI/ML. The provided text describes the device, its intended use, and indicates that "Performance data were submitted to characterize the Procyon Spinal System." However, the specific details of this performance data and any acceptance criteria are not included in the provided document snippet.
Therefore, I cannot provide the requested information.
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Procyon Spinal System
510(k) Application
JUN 0 3 2004
PREMARKET NOTIFICATION 510(K) SUMMARY B.
| Company: | NAS Medical Technologies, Inc.9191 Towne Centre Dr., Suite 395San Diego, CA 92122Phone: (858) 452-5589Fax: (858) 777-5790 |
|---|---|
| Contact: | Makoto Nonaka, M.D., Ph.D. |
| Proposed ProprietaryTrade Name: | Procyon Spinal System |
| Classification Name: | Spondylolisthesis spinal fixation device systemPedicle screw system |
| FDA Product CodeClassification: | MNI: 888. 3070, MNH: 888.3070 |
| Device Description: | The Procyon Spinal System consists of polyaxial screws,rods, and connecting components. The components arefabricated from titanium alloy (ASTM F-136). |
| Intended Use: | When used as a pedicle screw fixation system in the non-cervical spine of skeletally mature patients, the ProcyonSpinal System is intended for immobilization andstabilization of spinal segments as an adjunct to fusion in thetreatment of the following acute and chronic instabilities ordeformities of the thoracic, lumbar and sacral spine: 1)degenerative spondylolisthesis with objective evidence ofneurological impairment, 2) fracture, 3) dislocation, 4)scoliosis, 5) kyphosis, 6) spinal tumor and 7) failed previousfusion (pseudoarthrosis).In addition, when used as a pedicle screw fixation system, theProcyon Spinal System is intended for skeletally maturepatients: 1) having severe spondylolisthesis (Grades 3 and 4)of the L5-S1 vertebra, 2) who are receiving fusion byautogenous bone graft only; 3) who are having the devicefixed or attached to the lumbar and sacral spine (L3 andbelow); and 4) who are having the device removed after thedevelopment of a solid fusion mass. |
| Predicate Devices: | |
| Performance Data: | Performance data were submitted to characterize the ProcyonSpinal System. |
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 0 3 2004
Makoto Nonaka, M.D., Ph.D. NAS Medical Technologies, Inc. 9191 Towne Centre Drive, Suite 395 San Diego, California 92122
K033512 Re: Trade Name: Procyon Spinal System Regulation Number: 21 CFR 888.3070 (b) (1) Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class II Product Code: MNI, MNH Dated: March 22, 2004 Received: March 23, 2004
Dear Dr. Nonaka:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectorn o relay he 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 conninered prior to May 20, 1978, the ecoordance with the provisions of the Federal Food, DINA de nees that have been receasoned in assee approval of a premarket approval application (PMA). and Cosmetic Tor (1101) that do not require to the general controls provisions of the Act. The r ou may, mercerere, manel the Act include requirements for annual registration, listing of general controls provising 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 If your device is oneshined (see are roy als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of t may or subject to back addess the sublations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Dr. Mako Nonaka, M.D., Ph.D.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualic of a substantal equirements of the Act
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a delefinination that your cerred by other Federal agencies. You must or any Federal Statutes and regulations administered of not limited to: registration and listing (21 l comply with all the Act 3 requirements, moradice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sectroni CFR Part 807), labeling (21 CFR Part 800), good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000, 1050 forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action S product radiation control provisions (Sections 50 - 5 vice as described in your Section 510(k)
This letter will allow you to begin marketing your device of car device to legg I his letter will anow you to begin mankemig your avong equivalence of your device to a legally premarket nother in the PDA midning of backanding of 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 If you desire specific advice for your do rice at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain "Misoranding by reference to premainter nevilivans ander the Act from the Division of Small other general Information on your responsible and its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free number on the b Manufacturers, International and Coness http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Procyon Spinal System 510(k) Application
TAB 5. Labeling
A. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Procyon Spinal System
Indications for Use:
INTER used as a pedicle screw fixation system in the non-cervical spine of skeletally malure
s and as a provinced for a first and intended for mmobilization of spinal When used as a pedicle screw is intended for immobilization and stabilization of spinal
patients, the Procyon Spinal System is intreasonal of the following instabilities patients, the Procyon System is intended of the following acute and chronic instabilities.
segments as an adjunct to fusion in the treatment of the following acute and segments as an adjunct to fusion in the treatment of the following to the spondylolisthesis with
or deformities of the thoracic, lumbar and sacral spiric: 1) degenerative spo or deformities of the thoracio, lumbar and sacal spine. 1) degation, 4) scoliosis, 5)
objective evidence of neurological impairment, 2) fracture, 3) dislocationsis), objective evidence of neurological "Impanies")
kypohsis, 6) spinal tumor and 7) failed previous fusion (pseudoarthrosis).
In addition, when used as a pedicle screw fixation system, the Procyon Spinal System is
t Intended for skeletally mature patients: 1) having severe spondyblisthssis (Grades 3 and 4) of intended for skeletally mature patients: 1) having severe speners bone graft only; 3) who are
the L 5-S1 v ertebra, 2 ) w ho are receiving fusion by autogenous bone graft onl the L 5-S1 v ertebra, 2 ) who are receiving rushor and sacral some (L3 and below); and 4) who
having the device fixed or attached to the nament of a colid fusion nas having the device fixed of attached to the taken.
are having the device removed after the development of a solid fusion mass.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use __ or Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Division Sign-Off) Division of General, Restorative, and Neurological Devices K633512 510(k) Number.
N/A