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RSSCategory: CE & FDA

Covidien Introduces First FDA-Approved Spine Sealant

Akillas | November 12, 2009 | 0 Comments
Covidien Introduces First FDA-Approved Spine Sealant

NORTH HAVEN, Conn.–(BUSINESS WIRE)–Nov. 11, 2009– Covidien (NYSE: COV), a leading global provider of healthcare products, today announced the launch of DuraSeal™ spine sealant, the first product approved by the U.S. Food and Drug Administration (FDA) for intra-operative sealing of the dural membrane during spine procedures. Nearly 1.5 million spine surgeries are performed in the [...]

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Custom Spine Receives 510k Clearance of Regent ACP

Akillas | November 6, 2009 | 0 Comments
Custom Spine Receives 510k Clearance of Regent ACP

PARSIPPANY, N.J., Nov. 5 (HSMN NewsFeed) — Regent ACP, Custom Spine’s anterior cervical plate system, has received 510k Clearance from the U.S. Food and Drug Administration (FDA). This product clearance marks the latest addition to Custom Spine’s continually expanding product line.

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RSB Spine, LLC Announces FDA Clearance of New InterPlate(TM) Indications

Akillas | October 13, 2009 | 0 Comments
RSB Spine, LLC Announces FDA Clearance of New InterPlate(TM) Indications

CLEVELAND, Sept. 20 /PRNewswire/ — RSB Spine, LLC, today announced the U.S. Food and Drug Administration has cleared the cervical and lumbar InterPlate(TM) devices for use in intervertebral fusion procedures. Included are versions to be used with solid bone grafts and morselized bone, without the need for supplemental fixation.

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DuraSeal(TM) Spine Sealant Receives FDA Approval

Akillas | September 8, 2009 | 0 Comments
DuraSeal(TM) Spine Sealant Receives FDA Approval

WALTHAM, Mass.–(BUSINESS WIRE)–Sep. 8, 2009– Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has approved DuraSeal™ spine sealant for use in the United States. This is the first product that has been approved specifically as an adjunct to suturing for intra-operative dural sealing [...]

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