Acu-Sinch Repair System and Acumed Suture Anchor
FDA 510(k) K112111 · Acumed, LLC
510(k) numberK112111
Submission
- Device name
- Acu-Sinch Repair System and Acumed Suture Anchor
- Applicant
- Acumed, LLC
Hillsboro, OR, US - Received
- July 25, 2011
- Decision date
- November 14, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTN – Washer, Bolt Nut
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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More from Vilex, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K252356 | The Acumed Wrist Fixation System - 2.4mm ScrewsHRS · Special | 08/21/2025SE |
| K251132 | The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsHRS · Abbreviated | 07/14/2025SE |
| K251296 | The Acumed Wrist Fixation SystemHRS · Traditional | 06/18/2025SE |
| K243624 | Acu-Sinch Knotless MiniHTN · Traditional | 01/23/2025SE |
| K233311 | Acumed Wrist Plating SystemHRS · Traditional | 04/22/2024SE |
| K230744 | Acumed Acutrak 3 Headless Compression Screw SystemHWC · Traditional | 06/09/2023SE |
| K221333 | Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalHWC · Traditional | 12/29/2022SE |
| K212990 | Acumed Ankle Syndesmosis Repair SystemHTN · Traditional | 01/07/2022SE |
| K210750 | Acumed Clavicle Hook Plating SystemHRS · Traditional | 07/15/2021SE |
| K151886 | Acumed Ankle and Small Fragment Base Set UpdateHRS · Traditional | 10/30/2015SE |
Questions and answers
When was Acu-Sinch Repair System and Acumed Suture Anchor cleared by the FDA?
Acu-Sinch Repair System and Acumed Suture Anchor (K112111) received a 510(k) decision of Substantially Equivalent on November 14, 2011, 112 days after the submission was received.
What is the product code of K112111?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.