Sierra™

Basic Information

• Brand Name: Sierra™
• Primary DI: 10889981042998
• Version / Model: 50-5015
• Catalog Number: 50-5015
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• Labeler DUNS: 079840876
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 6
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 94d966b3-ffc6-45ab-a9c8-be8991686054
• Distribution End Date: 2016-09-02

Device Description

Occipital Screw, 15mm. 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNI	ORTHOSIS, SPINAL PEDICLE FIXATION	Orthopedic	888.3070	2
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	Orthopedic	888.3050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61235	Cannulated surgical drill bit, single-use	A metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10889981042998	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K062934	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			15mm