Identity
- Trade Name
- OCELOT FDA UDI
- Generic Name
- Polymeric spinal interbody fusion cage FDA UDI
- Device Name
- OCELOT STACKABLE CAGE SYSTEM MEDIUM CAGE, TOP 9mm FDA UDI
- Model / Reference
- 173401309 FDA UDI
- Description
- OCELOT STACKABLE CAGE SYSTEM MEDIUM CAGE, TOP 9mm FDA UDI
Identifiers
- Catalog Number
- 173401309 FDA UDI
- Primary DI / UDI-DI
- 10705034017082 FDA UDI
- 510(k) Number
- K001340 FDA UDI
- FDA Product Code
- MQP FDA UDI
- GMDN Term
- Polymeric spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Ocelot by Depuy Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K001340 also covers:
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
- Depuy Spine, Inc.
Sources (1)
- FDA UDI 5c1ca693-6144-4569-9113-b2a7e5a0ae57 37 fields · synced Jun 1, 2026