Medtronic CAPSTONE PTC 3992215 22x15mm Interbody Spacer

PRODUCT OVERVIEW

The Medtronic CAPSTONE PTC 3992215 is a titanium-coated polymeric interbody spacer measuring 22 mm x 15 mm.

The PTC platform combines a PEEK implant body with a pure titanium coating. This listing is for one spacer in its original Medtronic Sofamor Danek packaging.

PRODUCT DETAILS

Manufacturer: Medtronic Sofamor Danek, Inc.

Brand: CAPSTONE PTC Spinal System

Model: 3992215

Product Type: Polymeric Interbody Fusion Spacer

Dimensions: 22 mm x 15 mm

Material: Titanium-Coated PEEK

Primary GTIN: 00643169187481

Quantity: One Spacer

Condition: New in Original Manufacturer Packaging

Sterility: Manufacturer Supplied Sterile

Usage: Single-Use

Implantable: Yes

FDA Product Code: MAX

Premarket Submissions: K133205 and K172199

PACKAGE CONTENTS

One Medtronic CAPSTONE PTC 3992215 Interbody Spacer

Insertion instruments, trials, fixation components, and additional accessories are not included unless specifically pictured or stated.

STERILITY AND EXPIRATION

The product is considered manufacturer sterile when its original packaging and sterile barrier remain sealed, intact, undamaged, and within any applicable manufacturer-labeled expiration period.

Inventory is managed according to package condition and expiration range. The specific lot and expiration supplied may vary according to the option selected and available inventory.

Products beyond an applicable manufacturer expiration period are not represented as sterile or suitable for human clinical use. Expired inventory is offered only for permitted educational, training, demonstration, veterinary, or non-clinical research applications.

PURCHASER RESPONSIBILITY

The purchaser is responsible for confirming package integrity, sizing, compatibility, regulatory requirements, and the applicable manufacturer instructions before purchase or use.