Identity
- Trade Name
- GRAFTYS® QUICKSET KIT FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- Injectable Macroporous Calcium Phosphate FDA UDI
- Model / Reference
- 5cc FDA UDI
- Description
- Injectable Macroporous Calcium Phosphate FDA UDI
Identifiers
- Catalog Number
- QSMKITUSV1Q5 FDA UDI
- Primary DI / UDI-DI
- 03760177571396 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3045 FDA UDI
- 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
Yes
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 — 5 Milliliter FDA UDI
Category: Bone matrix implant, synthetic, non-antimicrobial
Graftys® Quickset Kit by Graftys — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone matrix implant, synthetic, non-antimicrobial.
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Cleared under the same submission
K093343 also covers:
- Arthrex® — Arthrex, Inc.
- Arthrex® — Arthrex, Inc.
- GRAFTYS® QUICKSET — GRAFTYS
- GRAFTYS® QUICKSET — GRAFTYS
- GRAFTYS® QUICKSET KIT — GRAFTYS
- GRAFTYS® QUICKSET KIT — GRAFTYS
- OrthoPediatrics QuickPack Bone Void Filler — ORTHOPEDIATRICS CORP.
- OrthoPediatrics QuickPack Bone Void Filler — ORTHOPEDIATRICS CORP.
- OrthoPediatrics QuickPack Bone Void Filler — ORTHOPEDIATRICS CORP.
- OrthoPediatrics QuickPack Bone Void Filler — ORTHOPEDIATRICS CORP.
- STRUCSURE — Smith & Nephew, Inc.
- STRUCSURE — Smith & Nephew, Inc.
K231714 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Graftys
Sources (1)
- FDA UDI 5d4cc4a9-9ef4-4753-b2b3-7cd39380c345 38 fields · synced May 30, 2026