Identity
- Trade Name
- iTotal® Impactor Head FDA UDI
- Generic Name
- Orthopaedic implant impactor, reusable FDA UDI
- Device Name
- iTotal® Impactor Head Reusable Instrument FDA UDI
- Model / Reference
- 1080-535 FDA UDI
- Description
- iTotal® Impactor Head Reusable Instrument FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850268007194 FDA UDI
- 510(k) Number
- K160025 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Orthopaedic implant impactor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 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
iTotal® Impactor Head by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K160025 also covers:
- iTotal® CR Tibial Keel Punch Tip — Conformis, Inc.
- iTotal® CR Tibial Keel Punch Tip — Conformis, Inc.
- iTotal® CR Tibial Keel Punch Tip — Conformis, Inc.
- iTotal® CR Tibial Tray Impactor Tip — Conformis, Inc.
- iTotal® Impactor Head — Conformis, Inc.
- iTotal® PS — Conformis, Inc.
- iTotal® PS — Conformis, Inc.
- iTotal® PS — Conformis, Inc.
- iTotal® PS — Conformis, Inc.
- iTotal® PS — Conformis, Inc.
- iTotal® PS — Conformis, Inc.
- iTotal® PS — Conformis, Inc.
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
- Conformis, Inc.
Sources (1)
- FDA UDI dbcc4757-ecfd-4d2f-b6bd-895cc7909dd6 36 fields · synced Jun 8, 2026