FDA 510(k)

Catalyst Bone Void Filler

K-Number: K232315 · 2023-09-15

Decision Date2023-09-15

Product CodeMQV

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Catalyst Bone Void Filler is a medical device manufactured by Ossdsign AB. It received FDA 510(k) clearance on 2023-09-15 under approval number K232315. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Catalyst Bone Void Filler?

Catalyst Bone Void Filler is a medical device that received FDA 510(k) clearance on 2023-09-15. It is manufactured by Ossdsign AB. The 510(k) number is K232315.

When was Catalyst Bone Void Filler approved by the FDA?

Catalyst Bone Void Filler received FDA 510(k) clearance on 2023-09-15, under approval number K232315.

What company makes Catalyst Bone Void Filler?

Catalyst Bone Void Filler is manufactured by Ossdsign AB.

What is the FDA product code for Catalyst Bone Void Filler?

The FDA product code for Catalyst Bone Void Filler is MQV.

Other Devices by Ossdsign AB

K161090Cranial PSI K181539OSSDSIGN Cranioplug K190523Cranial PSI Accessory Anatomical Model Original, Cranial PSI Accessory Anatomical Model Modified, Cranial PSI Accessory Plastic Drawing Guide, Cranial PSI Accessory Cranial Implant Trial K212414OSSDSIGN Cranial PSI

Related Devices (Code: MQV)

K160566Cerasorb Ortho FoamCurasan AG K160446MCP Bone PuttyBiostructures, LLC K161351NanoBone SBX PuttyArtoss GmbH K161447HydroSet XTOrthovita, Inc. K152077MaxiGenHans Biomed Corp. K151271BellaFuseHans Biomed Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.