Identity
- Trade Name
- Identity Imprint PS Knee Replacement System FDA UDI
- Generic Name
- Total knee prosthesis implantation guide-instrument kit FDA UDI
- Device Name
- PS Tibial INSTRUMENTS,ALL SIZES LEFT AND RIGHT FDA UDI
- Model / Reference
- TPS-000-D00T1 FDA UDI
- Description
- PS Tibial INSTRUMENTS,ALL SIZES LEFT AND RIGHT FDA UDI
Identifiers
- Catalog Number
- TPS-000-D00T FDA UDI
- Primary DI / UDI-DI
- M572TPS000D00T021 FDA UDI
- 510(k) Number
- K210191 FDA UDI
- FDA Product Code
- JWH FDA UDIOOG FDA UDIOIY FDA UDI
- GMDN Term
- Total knee prosthesis implantation guide-instrument kit 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
No
FDA UDI
Contains Latex
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total knee prosthesis implantation guide-instrument kit
Identity Imprint PS Knee Replacement System by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total knee prosthesis implantation guide-instrument kit.
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Cleared under the same submission
K210191 also covers:
- Identity Imprint Knee Replacement System — Conformis, Inc.
- Identity Imprint Knee Replacement System — Conformis, Inc.
- Identity Imprint Knee Replacement System — Conformis, Inc.
- Identity Imprint Knee Replacement System — Conformis, Inc.
- Identity Imprint Knee Replacement System — Conformis, Inc.
- Identity Imprint Knee Replacement System — Conformis, Inc.
- Identity Imprint Knee Replacement System — Conformis, Inc.
- Identity Imprint Knee Replacement System — Conformis, Inc.
- Identity Imprint Knee Replacement System — Conformis, Inc.
- Identity Imprint Knee Replacement System — Conformis, Inc.
- Identity Imprint Knee Replacement System — Conformis, Inc.
- Identity Imprint Knee Replacement System — 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 a96c691d-dc52-4e4c-bf4f-8384548644e9 37 fields · synced Jun 1, 2026