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InQu

by Isto Technologies, Inc. 2 variants

510(k) K063359

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

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK063359 Date16 Apr 2007ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MQV
Device class
Class II
Regulation
21 CFR Part 888.3045
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

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

The InQu is a biosynthetic bone graft extender and substitute, classified as a resorbable orthopedic device designed to facilitate bone regeneration. It is formulated to promote fusion without eliciting an immune response, providing a cell-friendly environment for natural healing processes. The material is intended for use in orthopedic procedures where bone augmentation or replacement is required, supporting structural integrity during the regenerative phase.

InQu is supplied as a sterile, single-use device and is intended for surgical use in orthopedic settings. It is regulated under FDA 510(k) clearance (K063359) as a substantially equivalent device to existing orthopedic graft substitutes. The product is packaged for one-time application and must be stored according to manufacturer guidelines to maintain sterility and efficacy. No additional regulatory approvals beyond the FDA clearance are stated in the provided data.

Similar devices

Other devices filed under FDA product code MQV (Filler, Bone Void, Calcium Compound).

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