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Twin Peaks

FDA UDI

Class I (US FDA UDI)

by Spineway SA

Identity

Trade Name
TWIN PEAKS FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
Sizer, 15mm, TLIF FDA UDI
Model / Reference
1 FDA UDI
Description
Sizer, 15mm, TLIF FDA UDI

Identifiers

Catalog Number
420DL15T1 FDA UDI
Primary DI / UDI-DI
03663422605634 FDA UDI
510(k) Number
K152355 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

Dimensions & Sizes

Size
Length — 15 Millimeter FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

Twin Peaks by Spineway SA — Class I — 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

K152355 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineway SA

Sources (1)

  • FDA UDI 571ab3e6-e296-4577-80b9-1e36da8c1e76 37 fields · synced May 31, 2026