Sierra™

FDA UDI

Class II (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name: Sierra™ FDA UDI
Generic Name: Cannulated surgical drill bit, single-use FDA UDI
Device Name: Sierra Screw, 04.0 x 10mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system. FDA UDI
Model / Reference: 50-4010 FDA UDI
Description: Sierra Screw, 04.0 x 10mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system. FDA UDI

Identifiers

Catalog Number: 50-4010 FDA UDI
Primary DI / UDI-DI: 10889981042554 FDA UDI
510(k) Number: K062934 FDA UDI
FDA Product Code: KWP FDA UDI
MNI FDA UDI
GMDN Term: Cannulated surgical drill bit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3050 FDA UDI
888.3070 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: Cannulated surgical drill bit, single-use

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

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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 96b48e34-bb2d-4a4e-9413-717e0c20e5ab 37 fields · synced Jun 8, 2026