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Fortress Pedicle Screw

FDA UDI

Class II (US FDA UDI)

by Spineology Inc.

Identity

Trade Name
Fortress Pedicle Screw FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
Pedicle Screw FDA UDI
Model / Reference
10-10-49-1 FDA UDI
Description
Pedicle Screw FDA UDI

Identifiers

Catalog Number
640-8570 FDA UDI
Primary DI / UDI-DI
M7406408570 FDA UDI
510(k) Number
K140010 FDA UDI
FDA Product Code
MNH FDA UDI
NKB FDA UDI
MNI FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Commercial Distribution
Not 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
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 70 Millimeter FDA UDI

Fortress Pedicle Screw by Spineology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K140010 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineology Inc.

Sources (1)

  • FDA UDI 8269b79e-337f-4442-ae00-ea12d364f089 38 fields · synced May 31, 2026