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Nitinex

FDA UDI

Class I (US FDA UDI)

by Vilex, Inc.

Identity

Trade Name
NITINEX FDA UDI
Generic Name
Orthopaedic bone staple drill bit FDA UDI
Device Name
NITINEX Implant Surgical Kit, 30mm x 30mm, Sterile FDA UDI
Model / Reference
SK-3030 FDA UDI
Description
NITINEX Implant Surgical Kit, 30mm x 30mm, Sterile FDA UDI

Identifiers

Catalog Number
SK-3030 FDA UDI
Primary DI / UDI-DI
00841731139962 FDA UDI
510(k) Number
K231493 FDA UDI
FDA Product Code
KDD FDA UDI
GMDN Term
Orthopaedic bone staple drill bit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

Yes

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 bone staple drill bit

Nitinex by Vilex, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone staple drill bit.

Cleared under the same submission

K231493 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vilex, Inc.

Sources (1)

  • FDA UDI e37086ff-a0c6-4e4e-8951-1fa986f3a1cf 35 fields · synced May 31, 2026