Identity
- Trade Name
- Fortress Set Screw FDA UDI
- Generic Name
- Spinal bone set screw FDA UDI
- Device Name
- Set Screw FDA UDI
- Model / Reference
- 10-10-53-1 FDA UDI
- Description
- Set Screw FDA UDI
Identifiers
- Catalog Number
- 640-5000 FDA UDI
- Primary DI / UDI-DI
- M7406405000 FDA UDI
- 510(k) Number
- K140010 FDA UDI
- FDA Product Code
- MNI FDA UDINKB FDA UDIMNH FDA UDI
- GMDN Term
- Spinal bone set screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Category: Spinal bone set screw
Fortress Set Screw by Spineology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone set screw.
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Cleared under the same submission
K140010 also covers:
- Fortress Pedicle Screw — SPINEOLOGY INC.
- Fortress Pedicle Screw — SPINEOLOGY INC.
- Fortress Pedicle Screw — SPINEOLOGY INC.
- Fortress Pedicle Screw — SPINEOLOGY INC.
- Fortress Pedicle Screw — SPINEOLOGY INC.
- Fortress Pedicle Screw — SPINEOLOGY INC.
- Fortress Pedicle Screw — SPINEOLOGY INC.
- Fortress Pedicle Screw — SPINEOLOGY INC.
- Fortress Pedicle Screw — SPINEOLOGY INC.
- Fortress Pedicle Screw — SPINEOLOGY INC.
- Fortress Pedicle Screw — SPINEOLOGY INC.
- Fortress Pedicle Screw — SPINEOLOGY 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spineology Inc.
Sources (1)
- FDA UDI 2b5022dd-e757-479d-8a37-66cb8ca3ad17 36 fields · synced May 30, 2026