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Graftys Quickset
FDA 510(k)FDA UDIClass II (US FDA 510(k))
510(k) K231714
by Graftys
Identity
- Trade Name
- GRAFTYS® QUICKSET FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- Injectable Macroporous Calcium Phosphate FDA UDI
- Model / Reference
- 8cc FDA UDI
- Description
- Injectable Macroporous Calcium Phosphate FDA UDI
Identifiers
- Catalog Number
- GYQSMUSV1Q8 FDA UDI
- Primary DI / UDI-DI
- 03760177571617 FDA UDI
- FDA Product Code
- MQV FDA 510(k)FDA UDI
- GMDN Term
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 888.3045 FDA 510(k)
- Regulation Number
- 888.3045 FDA 510(k)FDA UDI
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 8 Milliliter FDA UDI
Graftys Quickset by Graftys — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231714 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Graftys
Sources (2)
- FDA 510(k) K231714 24 fields · synced Jun 18, 2026
- FDA UDI ef5be79d-1047-40fa-b0b6-048077267a13 38 fields · synced May 27, 2026