Identity
- Trade Name
- RESTORIS FDA UDI
- Generic Name
- Orthopaedic implant impactor, reusable FDA UDI
- Device Name
- HIP OFFSET CUP IMPACTOR (TJO) FDA UDI
- Model / Reference
- 203505 FDA UDI
- Description
- HIP OFFSET CUP IMPACTOR (TJO) FDA UDI
Identifiers
- Catalog Number
- 203505 FDA UDI
- Primary DI / UDI-DI
- 00848486021641 FDA UDI
- 510(k) Number
- K121064 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Orthopaedic implant impactor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implant impactor, 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 implant impactor, reusable.
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- MobiliT Cup — CORIN LTD · Class II
- KMEDIC — TELEFLEX INCORPORATED · Class I
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- R3 — Smith & Nephew, Inc. · Class I
Cleared under the same submission
K121064 also covers:
- DYNASTY — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS, PST, RIO — MAKO Surgical Corp.
- RESTORIS, PST, RIO — MAKO Surgical Corp.
- RESTORIS, PST, RIO — MAKO Surgical Corp.
- RESTORIS, RIO — MAKO Surgical Corp.
- RESTORIS, RIO — MAKO Surgical Corp.
- RESTORIS, RIO — MAKO Surgical Corp.
- RESTORIS, TRINITY, RIO — MAKO Surgical Corp.
- RESTORIS, TRINITY, RIO — MAKO Surgical Corp.
- RIO — 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 0050ca7c-e98f-464c-935f-a8de4309a177 35 fields · synced Jun 9, 2026