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FDA 510(k)

BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT

K-Number: K991398 · 1999-09-22

ApplicantStryker Leibinger
Decision Date1999-09-22
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger. It received FDA 510(k) clearance on 1999-09-22 under 510(k) number K991398. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT?

BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT is a medical device that received FDA 510(k) clearance on 1999-09-22. The listed applicant is Stryker Leibinger. The 510(k) number is K991398.

When did BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT receive FDA 510(k) clearance?

BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT received FDA 510(k) clearance on 1999-09-22, under 510(k) number K991398.

Who is the listed applicant for BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT?

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

What is the FDA product code for BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT?

The FDA product code for BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT is GXP.

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Other records listing Stryker Leibinger 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.

K052871STRYKER CUSTOM TI IMPLANTK043250STRYKER PATIENT SPECIFIC POLYMER IMPLANTK041651STRYKER LEIBINGER SKELETAL ANCHORING SYSTEMK040022STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEMK022579STRYKER NAVIGATION SYSTEM-KNEE MODULEK023449NON-INVASIVE PATIENT FIXATION SYSTEM

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Related Devices (Code: GXP)

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.

K251959TnR Cranial ImplantT&R BIOFAB CO., Ltd.K261265Permatage XT Settable Bone PuttyOrthocon, Inc.K253732Permatage Flowable, Settable Bone PasteOrthocon, Inc.K253854MONTAGE XT Cranial CementOrthocon, Inc.K241027Permatage Settable Bone PuttyOrthocon, Inc.K232771Montage Flowable Settable, Resorbable Bone PasteOrthocon, 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.

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