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Eovia Calcium Phosphate Ceramic

by Ortho Tec, LLC

510(k) K040514

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

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040514 Date3 May 2004ClearedStatusActive

Recalls

0 recalls · FDA

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

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  • Withdrawn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

Overview

AI-generated summary, 6 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 Eovia Calcium Phosphate Ceramic is a synthetic, resorbable bone void filler designed to function as an osteoconductive scaffold for bone formation. It is intended for surgical use to fill non-structural bony voids or gaps in the skeletal system.

This device is available in granule or rod shapes and features interconnected porosity of 60-80%. It is resorbed and replaced with bone during the healing process.

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Questions

AI-generated answers, 6 Oct 2026

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

  • What is the Eovia Calcium Phosphate Ceramic used for?

    The Eovia Calcium Phosphate Ceramic is a synthetic, resorbable bone void filler. It is designed to act as an osteoconductive scaffold, supporting new bone formation in non-structural bony voids or gaps within the skeletal system.

  • In what forms is the Eovia Calcium Phosphate Ceramic available?

    This device is supplied in two distinct forms: granules or rods. Both forms feature an interconnected porosity ranging from 60% to 80%, which facilitates bone ingrowth.

  • Is the Eovia Calcium Phosphate Ceramic a permanent implant?

    The Eovia Calcium Phosphate Ceramic is designed to be resorbed by the body over time. As it resorbs, it is gradually replaced by new, natural bone during the healing process.