Biosorbfx Tack and Biosorbpdx Tack Bioabsorbable Fixation Fastener, Used with Plates
FDA 510(k) K003756 · Bionx Implants, Inc.
510(k) numberK003756
Submission
- Device name
- Biosorbfx Tack and Biosorbpdx Tack Bioabsorbable Fixation Fastener, Used with Plates
- Applicant
- Bionx Implants, Inc.
Blue Bell, PA, US - Received
- December 6, 2000
- Decision date
- January 3, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K013546 | Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214HWC · Special | 11/21/2001SE |
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| K012334 | Contour Meniscus Arrow, Models 541110, 541113, and 541116MAI · Special | 09/19/2001SE |
| K012001 | SmartscrewHWC · Special | 07/18/2001SE |
| K012000 | 1.5MM Bone Fixation KitHWC · Special | 07/18/2001SE |
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Questions and answers
When was Biosorbfx Tack and Biosorbpdx Tack Bioabsorbable Fixation Fastener, Used with Plates cleared by the FDA?
Biosorbfx Tack and Biosorbpdx Tack Bioabsorbable Fixation Fastener, Used with Plates (K003756) received a 510(k) decision of Substantially Equivalent on January 3, 2001, 28 days after the submission was received.
What is the product code of K003756?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.