Identity
- Trade Name
- RESTORIS FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- FEMORAL 1.75 INCH HEADED PIN FDA UDI
- Model / Reference
- 120209-4 FDA UDI
- Description
- FEMORAL 1.75 INCH HEADED PIN FDA UDI
Identifiers
- Catalog Number
- 120209-4 FDA UDI
- Primary DI / UDI-DI
- 00848486023508 FDA UDI
- FDA Product Code
- KRR FDA UDIHRY FDA UDIHSX FDA UDINPJ FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3540 FDA UDI888.3530 FDA UDI888.3520 FDA UDI888.3560 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
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
- Length — 1.75 Inch FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
Restoris by MAKO Surgical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.
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Cleared under the same submission
K082172 also covers:
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
K090763 also covers:
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
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
- MAKO Surgical Corp.
Sources (1)
- FDA UDI 8068393d-8190-4684-9b58-6aacf90da45b 36 fields · synced Jun 9, 2026