Identity
- Trade Name
- IDENTITY IMPRINT FDA UDI
- Generic Name
- Joint prosthesis implantation kit, single-use FDA UDI
- Device Name
- IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 5N 18MM LEFT AND RIGHT FDA UDI
- Model / Reference
- TCR-033-185N-01 FDA UDI
- Description
- IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 5N 18MM LEFT AND RIGHT FDA UDI
Identifiers
- Catalog Number
- TCR-033-185N FDA UDI
- Primary DI / UDI-DI
- M572TCR033185N011 FDA UDI
- 510(k) Number
- K230844 FDA UDI
- FDA Product Code
- JWH FDA UDIOIY FDA UDIOOG FDA UDI
- GMDN Term
- Joint prosthesis implantation kit, single-use 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Joint prosthesis implantation kit, single-use
Identity Imprint by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K230844 also covers:
- IDENTITY IMPRINT — Conformis, Inc.
- IDENTITY IMPRINT — Conformis, Inc.
- IDENTITY IMPRINT — Conformis, Inc.
- IDENTITY IMPRINT — Conformis, Inc.
- IDENTITY IMPRINT — Conformis, Inc.
- IDENTITY IMPRINT — Conformis, Inc.
- IDENTITY IMPRINT — Conformis, Inc.
- IDENTITY IMPRINT — Conformis, Inc.
- IDENTITY IMPRINT — Conformis, Inc.
- IDENTITY IMPRINT — Conformis, Inc.
- IDENTITY IMPRINT — Conformis, Inc.
- IDENTITY IMPRINT — 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 09d0640c-13c8-4891-8b9f-a8592f845915 36 fields · synced May 31, 2026