← Back to catalogue

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
Monoaxial Reduction Screw, 8.50 x 45mm FDA UDI
Model / Reference
SC-MR6-8545 FDA UDI
Description
Monoaxial Reduction Screw, 8.50 x 45mm FDA UDI

Identifiers

Primary DI / UDI-DI
M824SCMR685451 FDA UDI
510(k) Number
K062513 FDA UDI
K092825 FDA UDI
K102488 FDA UDI
K110906 FDA UDI
K132603 FDA UDI
FDA Product Code
NKB FDA UDI
MNH FDA UDI
KWQ FDA UDI
MNI FDA UDI
KWP 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

K062513 also covers:

K092825 also covers:

K102488 also covers:

K110906 also covers:

K132603 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Spinecraft Llc

Sources (1)

  • FDA UDI 56a0c290-f1ce-48a6-8ebc-43b7c6b0291f 36 fields · synced May 31, 2026