← Back to catalogue
iTotal Identity Knee Replacement System - Identity Imprint Knee Replacement System
FDA 510(k)Class II (US FDA 510(k))
510(k) K230846
Identifiers
- 510(k) Number
- K230846 FDA 510(k)
- FDA Product Code
- JWH FDA 510(k)
- Models / Variants
- iTotal Identity Knee Replacement System FDA 510(k)Identity Imprint Knee Replacement System FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3560 FDA 510(k)
- Regulation Number
- 888.3560 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
iTotal Identity Knee Replacement System - Identity Imprint Knee Replacement System by Conformis, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 2 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230846 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Conformis, Inc.
Sources (1)
- FDA 510(k) K230846 24 fields · synced Jun 18, 2026