Parcus Twist 4 5mm Peek Suture Anchor, Parcus Twist 5.5mm Peek Suture Anchor & …
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K120942 FDA 510(k)
- FDA Product Code
- MBI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Parcus Twist 4 5mm PEEK Suture Anchor, Parcus Twist 5.5mm PEEK Suture Anchor, and Parcus Triple Twist 5.5mm PEEK Suture Anchor are nondegradable soft tissue fixation devices. They are designed to secure soft tissue to bone using a suture anchor system.
These suture anchors are supplied sterile and are intended for single-use. They are available in 4.5 mm and 5.5 mm sizes and are cleared by the FDA under 510(k) number K120942.
Frequently asked questions
What is the Parcus Twist 5.5mm PEEK Suture Anchor used for?
The Parcus Twist 5.5mm PEEK Suture Anchor is a nondegradable soft tissue fixation device designed to secure soft tissue to bone using a suture anchor system.
Are these suture anchors sterile and intended for single use?
Yes, the Parcus Twist suture anchors are supplied sterile and are intended for single-use only.
What sizes are available for the Parcus Twist suture anchors?
The Parcus Twist suture anchors are available in 4.5 mm and 5.5 mm sizes.
What is the regulatory status of the Parcus Twist suture anchors?
The Parcus Twist suture anchors are cleared by the FDA under 510(k) number K120942.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Parcus Twist 4 5mm Peek Suture Anchor, Parcus Twist 5.5mm Peek Suture ..., Parcus Twist 4 5mm Peek Suture Anchor, Parcus Twist 5.5mm Peek Suture ..., PEEK Suture Anchor System - Acumed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120942 | Class II | Active |
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Manufacturer
- Manufacturer
- Parcus Medical Llc
- FDA Applicant
- Parcus Medical, LLC
Sources (1)
- FDA 510(k) K120942 24 fields · synced Sep 25, 2026