SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) January 16, 2001
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OSTEOTECH, INC.
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(Exact name of registrant as specified in its charter)
Delaware 0-19278 13-3357370
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(State or other jurisdiction (Commission file Number) (IRS Identification No.)
of incorporation)
51 James Way, Eatontown, New Jersey 07724
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (732) 542-2800
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(Former name or former address, if changed since last report)
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Item 5. Other Events
On January 16, 2001, Osteotech, Inc. announced that it has received notification
from the FDA of 510(k) clearance of the VBR(TM) (Vertebral Body Replacement)
Device. Osteotech is the exclusive distributor in the United States and Canada
for the device which is manufactured by Ulrich GmbH & Co., KG, Ulm, Germany. The
VBR(TM) System has been approved as 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)." To
the Company's knowledge, this is the first time the FDA has specifically cleared
any single device for either of these indications, which establishes a new
standard for this class of device.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Dated: January 17, 2001
OSTEOTECH, INC.
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(Registrant)
By: /s/ Michael J. Jeffries
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MICHAEL J. JEFFRIES
Executive Vice President,
Chief Financial Officer
(Principal Financial Officer
and Principal Accounting Officer)
