Identity
- Trade Name
- Cadence™ FDA UDI
- Generic Name
- Orthopaedic implant/instrument assembling device FDA UDI
- Device Name
- Cadence Tibial Impactor Stop is uses to prevent excesssive impaction of the Tibial Tray. The stop ensures that the implant is impacted only until the stop tabs contact the anterior tibia. FDA UDI
- Model / Reference
- 10203108 FDA UDI
- Description
- Cadence Tibial Impactor Stop is uses to prevent excesssive impaction of the Tibial Tray. The stop ensures that the implant is impacted only until the stop tabs contact the anterior tibia. FDA UDI
Identifiers
- Catalog Number
- 10203108 FDA UDI
- Primary DI / UDI-DI
- 10381780240297 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic implant/instrument assembling device FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
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: Orthopaedic implant/instrument assembling device
Cadence™ by Ascension Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant/instrument assembling device.
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- ACUMED — ACUMED LLC · Class I
- ACUMED — ACUMED LLC · Class I
- Invictus — ALPHATEC SPINE, INC. · Class I
- MOBIO™ Total Knee System — b-ONE Ortho Corp. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI ee556210-f7c4-48d5-b133-2a1b8e0e55bb 36 fields · synced May 30, 2026