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Calvary Spine Pedicle Screw System

FDA UDI

Class II (US FDA UDI)

by Calvary Spine, Llc

Identity

Trade Name
Calvary Spine Pedicle Screw System FDA UDI
Generic Name
Bone-screw internal spinal fixation system connector FDA UDI
Device Name
Illiac Connector 5.5mm Diameter 50mm Rod Length FDA UDI
Model / Reference
850 FDA UDI
Description
Illiac Connector 5.5mm Diameter 50mm Rod Length FDA UDI

Identifiers

Catalog Number
850 FDA UDI
Primary DI / UDI-DI
B1148500 FDA UDI
510(k) Number
K201568 FDA UDI
FDA Product Code
NKB FDA UDI
GMDN Term
Bone-screw internal spinal fixation system connector 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

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
MRI Safety
MR Conditional FDA UDI

Category: Bone-screw internal spinal fixation system connector

Calvary Spine Pedicle Screw System by Calvary Spine, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system connector.

Cleared under the same submission

K201568 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Calvary Spine, Llc

Sources (1)

  • FDA UDI 8ae2f486-3c49-4db2-a938-9506536400cc 35 fields · synced May 30, 2026