SwissGraft X
K-Number: K251613 · 2025-06-26
ApplicantGeistlich Pharma AG
Decision Date2025-06-26
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SwissGraft X is a medical device manufactured by Geistlich Pharma AG. It received FDA 510(k) clearance on 2025-06-26 under approval number K251613. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SwissGraft X?
SwissGraft X is a medical device that received FDA 510(k) clearance on 2025-06-26. It is manufactured by Geistlich Pharma AG. The 510(k) number is K251613.
When was SwissGraft X approved by the FDA?
SwissGraft X received FDA 510(k) clearance on 2025-06-26, under approval number K251613.
What company makes SwissGraft X?
SwissGraft X is manufactured by Geistlich Pharma AG.
What is the FDA product code for SwissGraft X?
The FDA product code for SwissGraft X is NPM.
Other Devices by Geistlich Pharma AG
K171050Geistlich Fibro-Gide
K171842Geistlich Wound Matrix
K171643Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed
K182838Geistlich Derma-Gide
K192042Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal
K190754Orthoss(R)
Related Devices (Code: NPM)
K151542A-OssHiossen, Inc.
K171008Anorganic Bone Mineral with Collagen in Delivery ApplicatorCollagen Matrix, Inc.
K163714OSSIX BONEDatum Dental, Ltd.
K170541Anorganic Bone Mineral in Delivery ApplicatorCollagen Matrix, Inc.
K170245DSM Biomedical Dental Bone GraftKensey Nash Corporation Dba Dsm Biomedical
K162158Porcine Anorganic Bone Mineral in Delivery ApplicatorCollagen Matrix, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.