Identity
- Trade Name
- STYLO FDA UDI
- Generic Name
- Metallic spinal fusion cage, non-sterile FDA UDI
- Model / Reference
- STT02007 FDA UDI
Identifiers
- Catalog Number
- STT02007 FDA UDI
- Primary DI / UDI-DI
- B638STT020070 FDA UDI
- 510(k) Number
- K180071 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Metallic spinal fusion cage, non-sterile 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Metallic spinal fusion cage, non-sterile
Stylo by Legend Spine Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic spinal fusion cage, non-sterile.
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Cleared under the same submission
K180071 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
- Legend Spine Llc
Sources (1)
- FDA UDI 7774c5ee-ca57-4c73-874c-fd874f41f230 34 fields · synced Jun 8, 2026