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CosmoLock Pedicle Screw System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K172808

by Kalitec Direct LLC

Identity

Trade Name
Cosmolock Pedicle Screw System FDA UDI
Generic Name
Bone-screw internal spinal fixation system connector FDA UDI
Device Name
Cross Connector, Fixed Arm, 26mm FDA UDI
Model / Reference
10-XLF-0026 FDA UDI
Description
Cross Connector, Fixed Arm, 26mm FDA UDI

Identifiers

Primary DI / UDI-DI
B07310XLF00260 FDA UDI
510(k) Number
K172808 FDA 510(k)FDA UDI
FDA Product Code
NKB FDA 510(k)FDA UDI
GMDN Term
Bone-screw internal spinal fixation system connector FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3070 FDA 510(k)
Regulation Number
888.3070 FDA 510(k)FDA UDI
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

CosmoLock Pedicle Screw System by Kalitec Direct LLC — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Kalitec Direct LLC
FDA Applicant
Kalitec Direct, LLC

Sources (2)

  • FDA 510(k) K172808 24 fields · synced Jun 18, 2026
  • FDA UDI a0a75d5c-8833-4f1d-a84a-425b3233703d 34 fields · synced May 27, 2026