Identity
- Trade Name
- Mx-Grafter FDA UDI
- Generic Name
- Bone collection scraper FDA UDI
- Device Name
- The Mx-Grafter Bone Grafting System is a manual, self-contained, sterile, single use instrument for the removal, harvest, and grafting of autogenous bone in surgical applications. The instrument is comprised of a plastic handle and stainless steel blade. The blade shaves bone from cortical surfaces producing short convoluted ribbons. While being cut, shavings combine with blood and flow into the handle. This graft material, an osseous coagulum, is then delivered with the handle directly to the recipient site, or to a bowl. FDA UDI
- Model / Reference
- 11302 FDA UDI
- Description
- The Mx-Grafter Bone Grafting System is a manual, self-contained, sterile, single use instrument for the removal, harvest, and grafting of autogenous bone in surgical applications. The instrument is comprised of a plastic handle and stainless steel blade. The blade shaves bone from cortical surfaces producing short convoluted ribbons. While being cut, shavings combine with blood and flow into the handle. This graft material, an osseous coagulum, is then delivered with the handle directly to the recipient site, or to a bowl. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860002195001 FDA UDI
- FDA Product Code
- GAC FDA UDIEMI FDA UDI
- GMDN Term
- Bone collection scraper FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI872.4565 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
No
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
Yes
FDA UDI
Category: Bone file/rasp, manual, reusableBone collection scraper
Mx-Grafter by Maxilon Laboratories Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone collection scraper.
- Safescraper Twist curve Volumizer — META TECHNOLOGIES SRL · Class I
- OSUNG MND — Osung Mnd Co., Ltd. · Class I
- Safescraper Twist — META TECHNOLOGIES SRL · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
- Safescraper Twist — META TECHNOLOGIES SRL · Class I
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC. · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Maxilon Laboratories Inc
Sources (1)
- FDA UDI 90ae6be7-5d27-475d-acd6-45aab1b395c0 34 fields · synced Jun 8, 2026