Bioretec Activascrew Interference
FDA 510(k) K130716 · Bioretec, Ltd.
510(k) numberK130716
Submission
- Device name
- Bioretec Activascrew Interference
- Applicant
- Bioretec, Ltd.
Tampere, FI - Received
- March 15, 2013
- Decision date
- August 28, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K254055 | OSSIOfiber® Suture AnchorMAI · Traditional | OSSIO , Ltd. | 02/24/2026SE |
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| K252946 | BioBrace® Extra-Articular Ligament Augmentation KitMAI · Special | Conmed Corporation | 10/15/2025SE |
| K252022 | OSSIOfiber® Interference ScrewMAI · Traditional | OSSIO , Ltd. | 08/19/2025SE |
| K251309 | OSSIOfiber® Suture AnchorMAI · Special | OSSIO , Ltd. | 05/27/2025SE |
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| K250528 | Stryker AlphaVent Knotless SP Biocomposite AnchorMAI · Traditional | Stryker Endoscopy | 05/21/2025SE |
More from Stryker Endoscopy
| 510(k) | Device | Decision |
|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | 09/04/2026SE |
| K133950 | Activapin HT, Fuse Link (Private Labled for Footmind, Inc.)HTY · Special | 01/22/2014SE |
| K080879 | Activatm Product Group Including Bioabsorbable Devices Activapin Fusion, Activanailtm…HTY · Traditional | 06/24/2008SE |
| K081392 | Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with ActivapinHWC · Special | 06/18/2008SE |
| K072848 | ActivascrewHWC · Special | 11/02/2007SE |
| K071863 | Activapin, Nexfix RFS Pin, Nexfix Resorbable Fixation System (RFS)HTY · Special | 08/31/2007SE |
| K062980 | ActivascrewHWC · Traditional | 11/22/2006SE |
| K061164 | ActivapinHTY · Traditional | 07/06/2006SE |
Questions and answers
When was Bioretec Activascrew Interference cleared by the FDA?
Bioretec Activascrew Interference (K130716) received a 510(k) decision of Substantially Equivalent on August 28, 2013, 166 days after the submission was received.
What is the product code of K130716?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.