[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]
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