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Cap Plus

by Etex Corp.

510(k) K063050

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 NumberK063050 Date19 Nov 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  • Withdrawn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 Cap Plus is a Bone Void Filler, Osteoinductive (without Human Growth Factor) (Product Code: MQV), designed to fill and stabilize bone defects during orthopedic procedures. It is a calcium phosphate-based material intended to promote bone regeneration and integration within the void space, aiding in the structural restoration of bone tissue. The device is classified as a Class II Orthopedic device under FDA regulations, requiring special controls to ensure safety and effectiveness.

Cap Plus is supplied as a sterile, single-use device and is intended for use in surgical settings where bone voids require filling. It is packaged in a sterile barrier system and must be handled using aseptic techniques. The device is cleared under the FDA’s Traditional 510(k) pathway (K063050) and is intended for orthopedic applications as defined by the Orthopedic (OR) Advisory Committee. No additional regulatory approvals beyond the stated 510(k) clearance are implied.

Similar devices

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

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