Identity
- Trade Name
- iDuo® iPoly™ Insert Kit FDA UDI
- Generic Name
- Unicondylar knee insert FDA UDI
- Device Name
- N/A FDA UDI
- Model / Reference
- RBK010070001 FDA UDI
- Description
- N/A FDA UDI
Identifiers
- Catalog Number
- RBK0100700 FDA UDI
- Primary DI / UDI-DI
- M572RBK0100700011 FDA UDI
- 510(k) Number
- K053488 FDA UDI
- FDA Product Code
- NPJ FDA UDIOOG FDA UDI
- GMDN Term
- Unicondylar knee insert FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Height — 7 Millimeter FDA UDI
iDuo® iPoly™ Insert Kit by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K053488 also covers:
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 fc06f6d7-b26b-4703-9290-3b4df7705144 38 fields · synced Jun 8, 2026