Identity
- Trade Name
- ProFx Spar Lift Assist FDA UDI
- Generic Name
- Leg intraoperative repositioning support FDA UDI
- Model / Reference
- 6850-7000 FDA UDI
Identifiers
- Catalog Number
- 6850-7000 FDA UDI
- Primary DI / UDI-DI
- 00842430111686 FDA UDI
- FDA Product Code
- JEA FDA UDI
- GMDN Term
- Leg intraoperative repositioning support FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4960 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Leg intraoperative repositioning support
ProFx Spar Lift Assist by Mizuho Orthopedic Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Leg intraoperative repositioning support.
- Blue Diamond — David Scott Company. · Class I
- DELUXE LEG PREP — AliMed, LLC · Class I
- Blue Diamond — David Scott Company. · Class I
- Blue Diamond — David Scott Company. · Class I
- ELBOW ARTHROSCOPY POSITIONER — AliMed, LLC · Class I
- ASSY, SPAR LIFT ASSIST DEVICE, REFURB — Mizuho Orthopedic Systems, 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
- Mizuho Orthopedic Systems, Inc.
Sources (1)
- FDA UDI f07013da-6eb0-4982-917b-d94f71741a30 34 fields · synced Jun 9, 2026