Identity
- Trade Name
- CATALYST® Reusable Instruments FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- INSTRUMENT 3289810 OBL PREC SPREADR 10MM FDA UDI
- Model / Reference
- 3289810 FDA UDI
- Description
- INSTRUMENT 3289810 OBL PREC SPREADR 10MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885074058153 FDA UDI
- 510(k) Number
- K090353 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
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: Orthopaedic prosthesis implantation positioning instrument, reusable
CATALYST® Reusable Instruments by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.
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Cleared under the same submission
K090353 also covers:
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- MSB VERTE-STACK Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- PERIMETER® Interbody Fusion Device — MEDTRONIC SOFAMOR DANEK, INC.
- PERIMETER® Interbody Fusion Device — MEDTRONIC SOFAMOR DANEK, INC.
- PERIMETER® Interbody Fusion Device — MEDTRONIC SOFAMOR DANEK, INC.
- PERIMETER® Interbody Fusion Device — MEDTRONIC SOFAMOR DANEK, INC.
- PERIMETER® Interbody Fusion Device — MEDTRONIC SOFAMOR DANEK, 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
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 59966af0-c808-4e0c-9735-53a332d176f6 36 fields · synced May 30, 2026