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FDA 510(k)

OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER

K-Number: K050490 · 2005-04-11

ApplicantMedicrea
Decision Date2005-04-11
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea. It received FDA 510(k) clearance on 2005-04-11 under 510(k) number K050490. 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 OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER?

OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER is a medical device that received FDA 510(k) clearance on 2005-04-11. The listed applicant is Medicrea. The 510(k) number is K050490.

When did OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER receive FDA 510(k) clearance?

OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER received FDA 510(k) clearance on 2005-04-11, under 510(k) number K050490.

Who is the listed applicant for OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER?

The FDA 510(k) record lists Medicrea as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER?

The FDA product code for OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER is MQV.

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Other records listing Medicrea as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K100484IMPIX MANTA CERVICAL INTERBODY DEVICEK062136PASS 2 SPINAL SYSTEMK032094PASSMED SPINAL SYSTEM

Related Devices (Code: MQV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.K260364Device 300419 StripGeistlich Pharma AGK252797JAZBI™ Resorbable Bone Void FillerSdip Innovations Pty, Ltd.K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft SubstituteStryker SpineK253524Adaptos®Fuse Bone GraftBiomendex OYK253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft SubstituteProsidyan, Inc.

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.

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