Identity
- Trade Name
- iTotal® Poly Impactor Tip FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- iTotal® Poly Impactor Tip Reusable Instrument FDA UDI
- Model / Reference
- 1080-549 FDA UDI
- Description
- iTotal® Poly Impactor Tip Reusable Instrument FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850268007453 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, 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 prosthesis implantation positioning instrument, reusable
iTotal® Poly Impactor Tip by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K161366 also covers:
- iTotal® CR iPoly® Insert Kit — Conformis, Inc.
- iTotal® CR iPoly® Insert Kit — Conformis, Inc.
- iTotal® CR iPoly® Insert Kit — Conformis, Inc.
- iTotal® CR iPoly® Insert Kit — Conformis, Inc.
- iTotal® CR iPoly® Insert Kit — Conformis, Inc.
- iTotal® CR iPoly® Insert Kit — Conformis, Inc.
- iTotal® CR iPoly® Insert Kit — Conformis, Inc.
- iTotal® CR iPoly® Insert Kit — Conformis, Inc.
- iTotal® CR iPoly® Insert Kit — Conformis, Inc.
- iTotal® CR iPoly® Insert Kit — Conformis, Inc.
- iTotal® CR iPoly® Insert Kit — Conformis, Inc.
- iTotal® CR iPoly® Insert Kit — Conformis, Inc.
K161668 also covers:
- iTotal PS Knee Replacement System — Conformis, Inc.
- iTotal® PS Tibial Keel Punch Tip — Conformis, Inc.
- iTotal® PS Tibial Keel Punch Tip — Conformis, Inc.
- iTotal® PS Tibial Keel Punch Tip — Conformis, Inc.
- iTotal® PS iPoly® Insert Kit — Conformis, Inc.
- iTotal® PS iPoly® Insert Kit — Conformis, Inc.
- iTotal® PS iPoly® Insert Kit — Conformis, Inc.
- iTotal® PS iPoly® Insert Kit — Conformis, Inc.
- iTotal® PS iPoly® Insert Kit — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Conformis, Inc.
Sources (1)
- FDA UDI 7bc6f1ec-1342-46ae-8f7a-bb9bb8a460ec 36 fields · synced Jun 1, 2026