[Federal Register Volume 61, Number 223 (Monday, November 18, 1996)]
[Notices]
[Page 58696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29394]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96M-0424]
Spine-Tech, Inc.; Premarket Approval of BAKTM Interbody
Fusion System With Instrumentation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing its
approval of the application by Spine-Tech, Inc., Minneapolis, MN, for
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the
act), of the BAKTM Interbody Fusion System with instrumentation.
After reviewing the recommendation of the Orthopedic and Rehabilitation
Devices Panel, FDA's Center for Devices and Radiological Health (CDRH)
notified the applicant, by letter of September 20, 1996, of the
approval of the application.
DATES: Petitions for administrative review by December 18, 1996.
ADDRESSES: Written requests for copies of the summary of safety and
effectiveness data and petitions for administrative review to the
Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Mark N. Melkerson, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2036.
SUPPLEMENTARY INFORMATION: On August 28, 1995, Spine-Tech, Inc.,
Minneapolis, MN 55439-2029, submitted to CDRH an application for
premarket approval of the BAKTM Interbody Fusion System with
instrumentation. This device is an intervertebral body fusion device.
It is indicated for use with autogenous bone graft in patients with
degenerative disc disease (DDD) at one or two contiguous levels from
L2-S1. These DDD patients may also have up to Grade I spondylolisthesis
or retrolisthesis at the involved level(s). BAKTM devices are to
be implanted via an open anterior or posterior approach. DDD is defined
as discogenic back pain with degeneration of the disc confirmed by
history and radiographic studies. These patients should be skeletally
mature and have had 6 months of nonoperative treatment.
On May 23, 1996, the Orthopedic and Rehabilitation Devices Panel of
the Medical Devices Advisory Committee, an FDA advisory committee,
reviewed and recommended approval of the application. On September 20,
1996, CDRH approved the application by a letter to the applicant from
the Director of the Office of Device Evaluation, CDRH.
A summary of the safety and effectiveness data on which CDRH based
its approval is on file in the Dockets Management Branch (address
above) and is available from that office upon written request. Requests
should be identified with the name of the device and the docket number
found in brackets in the heading of this document.
Opportunity For Administrative Review
Section 515(d)(3) of the act (21 U.S.C. 360e(d)(3)) authorizes any
interested person to petition, under section 515(g) of the act, for
administrative review of CDRH's decision to approve this application. A
petitioner may request either a formal hearing under 21 CFR part 12 of
FDA's administrative practices and procedures regulations or a review
of the application and CDRH's action by an independent advisory
committee of experts. A petition is to be in the form of a petition for
reconsideration under 21 CFR 10.33(b). A petitioner shall identify the
form of review requested (hearing or independent advisory committee)
and shall submit with the petition supporting data and information
showing that there is a genuine and substantial issue of material fact
for resolution through administrative review. After reviewing the
petition, FDA will decide whether to grant or deny the petition and
will publish a notice of its decision in the Federal Register. If FDA
grants the petition, the notice will state the issue to be reviewed,
the form of the review to be used, the persons who may participate in
the review, the time and place where the review will occur, and other
details.
Petitioners may, at any time on or before December 18, 1996, file
with the Dockets Management Branch (address above) two copies of each
petition and supporting data and information, identified with the name
of the device and the docket number found in brackets in the heading of
this document. Received petitions may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
This notice is issued under the Federal Food, Drug, and Cosmetic
Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10)
and redelegated to the Director, Center for Devices and Radiological
Health (21 CFR 5.53).
Dated: October 24, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 96-29394 Filed 11-15-96; 8:45 am]
BILLING CODE 4160-01-F
