Identity
- Trade Name
- Engage Partial Knee System FDA UDI
- Generic Name
- Intraoperative bone pin/screw, non-sterile FDA UDI
- Device Name
- 3.2MM Threaded Pin 45MM Pin w/ Collar 4/Pk FDA UDI
- Model / Reference
- 1-50100-445 FDA UDI
- Description
- 3.2MM Threaded Pin 45MM Pin w/ Collar 4/Pk FDA UDI
Identifiers
- Primary DI / UDI-DI
- B6951501004450 FDA UDI
- 510(k) Number
- K190439 FDA UDI
- FDA Product Code
- NJD FDA UDIHSX FDA UDI
- GMDN Term
- Intraoperative bone pin/screw, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3535 FDA UDI888.3520 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Intraoperative bone pin/screw, non-sterile
Engage Partial Knee System by Engage Uni, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Intraoperative bone pin/screw, non-sterile.
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Cleared under the same submission
K190439 also covers:
- Engage Partial Knee System — Engage Uni, LLC
- Engage Partial Knee System — Engage Uni, LLC
- Engage Partial Knee System — Engage Uni, LLC
- Engage Partial Knee System — Engage Uni, LLC
- Engage Partial Knee System — Engage Uni, LLC
- Engage Partial Knee System — Engage Uni, LLC
- Engage Partial Knee System — Engage Uni, LLC
- Engage Partial Knee System — Engage Uni, LLC
- Engage Partial Knee System — Engage Uni, LLC
- Engage Partial Knee System — Engage Uni, LLC
- Engage Partial Knee System — Engage Uni, LLC
- Engage Partial Knee System — Engage Uni, LLC
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
- Engage Uni, LLC
Sources (1)
- FDA UDI 23b96969-79d8-424d-a77d-f3749dac3513 35 fields · synced May 30, 2026