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M6-C

FDA UDI

Class II (US FDA UDI)

by Spinal Kinetics, LLC

Identity

Trade Name
M6-C FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
M6-C Single Use, Disposable Instrumentation: Mallet FDA UDI
Model / Reference
1503-4100.90 FDA UDI
Description
M6-C Single Use, Disposable Instrumentation: Mallet FDA UDI

Identifiers

Catalog Number
CIK-300-08 FDA UDI
Primary DI / UDI-DI
00812388032609 FDA UDI
510(k) Number
K241117 FDA UDI
FDA Product Code
QLQ FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.4515 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

Category: Orthopaedic surgical procedure kit, non-medicated, single-use

M6-C by Spinal Kinetics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, single-use.

Cleared under the same submission

K241117 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spinal Kinetics, LLC

Sources (1)

  • FDA UDI 53cb89fe-013d-4230-bc4d-63d7836885aa 35 fields · synced May 30, 2026