Sierra™

FDA UDI

Class II (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name: Sierra™ FDA UDI
Generic Name: Vertebral body prosthesis, non-sterile FDA UDI
Device Name: S2S CrossBar, 27 - 35mm FDA UDI
Model / Reference: 50-2022 FDA UDI
Description: S2S CrossBar, 27 - 35mm FDA UDI

Identifiers

Catalog Number: 50-2022 FDA UDI
Primary DI / UDI-DI: 10889981059156 FDA UDI
510(k) Number: K072729 FDA UDI
FDA Product Code: KWP FDA UDI
GMDN Term: Vertebral body prosthesis, non-sterile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Vertebral body prosthesis, non-sterile

Sierra™ by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Vertebral body prosthesis, non-sterile.

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HONOUR™ Spacer System — NEXXT SPINE LLC · Class II
Apache — Genesys Orthopedics Systems LLC · Class II
HONOUR™ Spacer System — NEXXT SPINE LLC · Class II
HONOUR™ Spacer System — NEXXT SPINE LLC · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: SeaSpine Orthopedics Corporation

Sources (1)

FDA UDI 709fa524-8a85-4d97-a6d5-a6f900933d2b 37 fields · synced Jun 8, 2026