Biosorbfx 1.5/2.0 Bioabsorbable Fixation System
FDA 510(k) K982139 · Bionx Implants, Inc.
510(k) numberK982139
Submission
- Device name
- Biosorbfx 1.5/2.0 Bioabsorbable Fixation System
- Applicant
- Bionx Implants, Inc.
Washington, DC, US - Received
- June 17, 1998
- Decision date
- September 15, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Biosorbfx 1.5/2.0 Bioabsorbable Fixation System cleared by the FDA?
Biosorbfx 1.5/2.0 Bioabsorbable Fixation System (K982139) received a 510(k) decision of Substantially Equivalent on September 15, 1998, 90 days after the submission was received.
What is the product code of K982139?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.