SIGNAFUSE Bioactive Strip - SIGNAFUSE Putty
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233490 FDA 510(k)
- FDA Product Code
- MQV FDA 510(k)
- Models / Variants
- SIGNAFUSE Bioactive Strip (SBS) FDA 510(k)SIGNAFUSE Putty FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3045 FDA 510(k)
- Regulation Number
- 888.3045 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
SIGNAFUSE Bioactive Strip (SBS) is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone.
SIGNAFUSE Bioactive Strip (SBS) is indicated to be combined with autologous bone marrow aspirate. The device is supplied as a sterile, single-use implant. It is regulated as a Class II medical device under product code MQV and 21 CFR 888.3045, with FDA 510(k) clearance under K233490.
Frequently asked questions
What is SIGNAFUSE Bioactive Strip (SBS) used for?
SIGNAFUSE Bioactive Strip (SBS) is intended for use in bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure, such as surgically created defects or those resulting from traumatic injury, and is indicated to be combined with autologous bone marrow aspirate.
How is SIGNAFUSE Bioactive Strip (SBS) supplied and is it sterile or reusable?
SIGNAFUSE Bioactive Strip (SBS) is supplied as a sterile, single-use implant, meaning it is provided in a sterile condition and intended for one-time use only, with no reprocessing or reuse permitted.
What regulatory pathway and product code apply to SIGNAFUSE Bioactive Strip (SBS)?
SIGNAFUSE Bioactive Strip (SBS) is regulated as a Class II medical device under product code MQV and 21 CFR 888.3045, and received FDA 510(k) clearance under submission number K233490.
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: SIGNAFUSE - Bioventus Surgical, PDF Scott Bruder Founder & CEO 268 Glen Place Regulation Number: 21 CFR 888 ..., SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233490 | Class II | Active |
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Manufacturer
- Manufacturer
- Bioventus Llc
- FDA Applicant
- Bioventus, LLC
Sources (1)
- FDA 510(k) K233490 24 fields · synced Oct 1, 2026