The Grapplr And Grapplr Extender

by Tag Medical Corp.

510(k) K101616

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K101616↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK101616	Date6 Jan 2011Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K101616
FDA Product Code: MBI

Device Class: Class II
Regulation: 21 CFR Part 888.3040
Advisory Committee: Orthopedic
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Grapplr And Grapplr Extender is a device intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or assist in reconstruction surgeries and to assist in the management of reconstructive surgeries. It is classified under the product code MBI, which is related to orthopedic devices.

The Grapplr And Grapplr Extender is supplied by Tag Medical Corp. and has been authorized with FDA 510K clearance, with the decision code SESE. The device has a specific k number, K101616, and is associated with the advisory committee description Orthopedic. The device is used in orthopedic applications, and its storage and handling requirements are not specified in the provided data.