Parcus V-Lox Peek Cf Suture Anchor, Models: 10253, 10254, 10263, 10264
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K091094 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 V-Lox Peek Cf Suture Anchor is a device used for attachment of soft tissue to bone. It is indicated for use in orthopedic applications, including shoulder and joint repairs. The device is made from carbon fiber reinforced PEEK-OPTIMA. The models included are 10253, 10254, 10263, and 10264.
The Parcus V-Lox Peek Cf Suture Anchor is supplied in various models and is intended for use in orthopedic procedures. It has been found substantially equivalent by the FDA. The device is classified as a class 2 device and has a traditional clearance type. It is regulated under regulation number 888.3040.
Frequently asked questions
What is the Parcus V-Lox PEEK CF Suture Anchor used for?
The Parcus V-Lox PEEK CF Suture Anchor is used for attachment of soft tissue to bone in orthopedic applications, including shoulder and joint repairs.
What material is the Parcus V-Lox PEEK CF Suture Anchor made of?
The device is made from carbon fiber reinforced PEEK-OPTIMA.
What models of the Parcus V-Lox PEEK CF Suture Anchor are available?
The available models are 10253, 10254, 10263, and 10264.
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 V-lox Peek Cf Suture Anchor, Models: 10253, 10254, 10263, 10264 ..., Parcus V-lox Peek Cf Suture Anchor, Models: 10253, 10254, 10263, 10264 ..., Parcus - Ossi, Parcus V-lox Peek Cf Suture Anchor, Models: 10253, 10254, 10263, 10264
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K091094 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Parcus Medical Llc
- FDA Applicant
- Parcus Medical, LLC
Sources (1)
- FDA 510(k) K091094 24 fields · synced Sep 21, 2026