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airlock®

FDA UDI

Class II (US FDA UDI)

by Novastep

Identity

Trade Name
airlock® FDA UDI
Generic Name
Surgical implant template, reusable FDA UDI
Device Name
MT Open wedge 3 trial plate left FDA UDI
Model / Reference
XTI02013 FDA UDI
Description
MT Open wedge 3 trial plate left FDA UDI

Identifiers

Catalog Number
XTI02013 FDA UDI
Primary DI / UDI-DI
03700879503226 FDA UDI
510(k) Number
K151277 FDA UDI
FDA Product Code
HRS FDA UDI
GMDN Term
Surgical implant template, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical implant template, reusable

airlock® by Novastep — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical implant template, reusable.

Cleared under the same submission

K151277 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novastep

Sources (1)

  • FDA UDI faedd8d2-6e89-44eb-afe5-1d68e293368f 36 fields · synced May 31, 2026