Identifiers
- 510(k) Number
- K122871 FDA 510(k)
- FDA Product Code
- JDR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Compressyn Staple is an orthopedic device used for compression fixation in bone stabilization procedures. It is designed to provide secure fixation during surgical interventions involving bone alignment and stabilization.
The Compressyn Staple is supplied as a single-use device and requires appropriate storage conditions as specified by the manufacturer. It has received FDA 510(k) clearance with product code JDR and is intended for use in orthopedic applications as determined by the review advisory committee.
Frequently asked questions
What is the Compressyn Staple used for?
The Compressyn Staple is an orthopedic device designed for compression fixation in bone stabilization procedures during surgical interventions involving bone alignment and stabilization.
Is the Compressyn Staple single-use or reusable?
The Compressyn Staple is supplied as a single-use device and requires appropriate storage conditions as specified by the manufacturer to maintain its integrity and functionality.
What regulatory approvals does the Compressyn Staple have?
The Compressyn Staple has received FDA 510(k) clearance with product code JDR and is intended for orthopedic applications as determined by the review advisory committee.
How is the Compressyn Staple supplied?
The Compressyn Staple is supplied as a single-use device with specific storage conditions required as per the manufacturer's instructions to ensure proper performance and safety.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122871 | Class II | Active |
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Manufacturer
- Manufacturer
- Dallen Medical, Inc.
Sources (1)
- FDA 510(k) K122871 24 fields · synced Sep 23, 2026