Identity
- Trade Name
- Nano fx® FDA UDI
- Generic Name
- Subchondral bone needling device FDA UDI
- Device Name
- Pleuristik Nano-Fracture FDA UDI
- Model / Reference
- FURS-2001 FDA UDI
- Description
- Pleuristik Nano-Fracture FDA UDI
Identifiers
- Catalog Number
- FURS-2001 FDA UDI
- Primary DI / UDI-DI
- M528FURS20010 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Subchondral bone needling device FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Subchondral bone needling device
Nano fx® by Arthrosurface Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Subchondral bone needling device.
- SmartShot Ankle — MARROW ACCESS TECHNOLOGIES · Class I
- SmartShot — MARROW ACCESS TECHNOLOGIES · Class I
- Nano fx® — ARTHROSURFACE INCORPORATED · Class I
- Nano fx® — ARTHROSURFACE INCORPORATED · Class I
- Nano fx® — ARTHROSURFACE INCORPORATED · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Arthrosurface Incorporated
Sources (1)
- FDA UDI eafb8d5a-d8e3-4921-a9c2-ddd5a66e75bc 35 fields · synced May 30, 2026