Xsorb Bioabsorbable Craniofacial Bone Fixation System & Accessories
FDA 510(k) K070737 · Prosurg, Inc.
510(k) numberK070737
Submission
- Device name
- Xsorb Bioabsorbable Craniofacial Bone Fixation System & Accessories
- Applicant
- Prosurg, Inc.
San Jose, CA, US - Received
- March 16, 2007
- Decision date
- July 25, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Xsorb Bioabsorbable Craniofacial Bone Fixation System & Accessories cleared by the FDA?
Xsorb Bioabsorbable Craniofacial Bone Fixation System & Accessories (K070737) received a 510(k) decision of Substantially Equivalent on July 25, 2007, 131 days after the submission was received.
What is the product code of K070737?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.