← Back to catalogue

Lantern

FDA UDI

Class II (US FDA UDI)

by Orthalign, Inc.

Identity

Trade Name
Lantern FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
Top-Level Caddy Set, Shims FDA UDI
Model / Reference
405316 FDA UDI
Description
Top-Level Caddy Set, Shims FDA UDI

Identifiers

Catalog Number
405316 FDA UDI
Primary DI / UDI-DI
00810832032373 FDA UDI
510(k) Number
K200892 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 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: Orthopaedic surgical procedure kit, non-medicated, reusable

Lantern by Orthalign, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K200892 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Orthalign, Inc.

Sources (1)

  • FDA UDI 3ab59af1-2ff2-4c1a-82c4-ff841508622c 36 fields · synced Jun 8, 2026