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iTotal Identity CR Knee Replacement System (with CS Insert)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- iTotal Identity CR Knee Replacement System (with CS Insert) FDA UDI
- Generic Name
- Tibial insert FDA UDI
- Device Name
- ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 9MM, LEFT OR RIGHT FDA UDI
- Model / Reference
- RCR013090D01 FDA UDI
- Description
- ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 9MM, LEFT OR RIGHT FDA UDI
Identifiers
- Catalog Number
- RCR-013-090D FDA UDI
- Primary DI / UDI-DI
- M572RCR013090D011 FDA UDI
- 510(k) Number
- K210809 FDA UDI
- FDA Product Code
- JWH FDA UDIOIY FDA UDIOOG FDA UDI
- GMDN Term
- Tibial insert 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Tibial insert
iTotal Identity CR Knee Replacement System (with CS Insert) by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tibial insert.
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Cleared under the same submission
K210809 also covers:
- iTotal Identity CR Knee Replacement System (with CS Insert) — Conformis, Inc.
- iTotal Identity CR Knee Replacement System (with CS Insert) — Conformis, Inc.
- iTotal Identity CR Knee Replacement System (with CS Insert) — Conformis, Inc.
- iTotal Identity CR Knee Replacement System (with CS Insert) — Conformis, Inc.
- iTotal Identity CR Knee Replacement System (with CS Insert) — Conformis, Inc.
- iTotal Identity CR Knee Replacement System (with CS Insert) — Conformis, Inc.
- iTotal Identity CR Knee Replacement System (with CS Insert) — Conformis, Inc.
- iTotal Identity CR Knee Replacement System (with CS Insert) — Conformis, Inc.
- iTotal Identity CR Knee Replacement System (with CS Insert) — Conformis, Inc.
- iTotal Identity CR Knee Replacement System (with CS Insert) — Conformis, Inc.
- iTotal Identity CR Knee Replacement System (with CS Insert) — Conformis, Inc.
- iTotal Identity CR Knee Replacement System (with CS Insert) — 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 6581811c-db85-487d-81f7-c754563bdf06 37 fields · synced Jun 8, 2026