Wishbone HA

FDA 510(k) K211551 · Wishbone SA

Substantially Equivalent

510(k) numberK211551

Submission

Device name
Wishbone HA
Applicant
Wishbone SA
Flemalle, BE
Received
May 19, 2021
Decision date
August 20, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NPM – Bone Grafting Material, Animal Source
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3930
Specialty
Dental
Implant
Yes

A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.

Other 510(k)s with product code NPM

510(k)DeviceApplicantDecision
K253723BossNPM · Traditional Medpark Co., Ltd.06/16/2026SE
K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®NPM · Special Geistlich Pharma AG07/11/2025SE
K251613SwissGraft XNPM · Special Geistlich Pharma AG06/26/2025SE
K242510Geistlich Bio-Flow®NPM · Traditional Geistlich Pharma AG03/07/2025SE
K240133Xenograft Bovine Bone ParticulateNPM · Traditional Collagen Solutions, LLC08/16/2024SE
K230305THE Graft CollagenNPM · Traditional Purgo Biologics, Inc.07/24/2024SE
K240661Geistlich Bio-Oss®NPM · Traditional Geistlich Pharma AG07/12/2024SE
K231672S1NPM · Traditional Medpark Co., Ltd.10/13/2023SE
K221808InterOss CollagenNPM · Traditional Sigmagraft, Inc.03/18/2023SE
K202183Porcine Mineral Collagen CompositeNPM · Traditional Collagen Matrix, Inc.04/02/2021SE

Questions and answers

When was Wishbone HA cleared by the FDA?

Wishbone HA (K211551) received a 510(k) decision of Substantially Equivalent on August 20, 2021, 93 days after the submission was received.

What is the product code of K211551?

The FDA product code is NPM – Bone Grafting Material, Animal Source, a Class II (moderate risk) device regulated under 21 CFR 872.3930.