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APEX Spine System

FDA UDI

Class II (US FDA UDI)

by Spinecraft Llc

Identity

Trade Name
APEX Spine System FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
Uniplanar Reduction Screw, 4.75 x 45mm, Self-Tapping FDA UDI
Model / Reference
SC-UR6-4745-F FDA UDI
Description
Uniplanar Reduction Screw, 4.75 x 45mm, Self-Tapping FDA UDI

Identifiers

Primary DI / UDI-DI
M824SCUR64745F1 FDA UDI
510(k) Number
K110906 FDA UDI
K132603 FDA UDI
FDA Product Code
MNI FDA UDI
NKB FDA UDI
KWQ FDA UDI
KWP FDA UDI
MNH FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3060 FDA UDI
888.3050 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

APEX Spine System by Spinecraft Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K110906 also covers:

K132603 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spinecraft Llc

Sources (1)

  • FDA UDI a2eb264d-1823-48c0-800e-49c8d4a0b298 36 fields · synced Jun 6, 2026