Identity
- Trade Name
- MAKO Swing Arm FDA UDI
- Generic Name
- Leg procedure positioner FDA UDI
- Device Name
- MAKO Adjustable Swing Arm (includes support bar) FDA UDI
- Model / Reference
- 108MB FDA UDI
- Description
- MAKO Adjustable Swing Arm (includes support bar) FDA UDI
Identifiers
- Catalog Number
- 108MB FDA UDI
- Primary DI / UDI-DI
- 00696588000817 FDA UDI
- FDA Product Code
- FWZ FDA UDI
- GMDN Term
- Leg procedure positioner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4950 FDA UDI
- Commercial Distribution
- Not 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
Moist Heat or Steam Sterilization FDA UDI
MAKO Swing Arm by Innovative Medical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Innovative Medical Products, Inc.
Sources (1)
- FDA UDI d0b77a7d-369e-4559-a08b-4c5d68259a9b 35 fields · synced Jun 1, 2026