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FDA 510(k)

AAP BONE PLATE

K-Number: K915315 · 1992-02-20

ApplicantAap International, Ltd.
Decision Date1992-02-20
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AAP BONE PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Aap International, Ltd.. It received FDA 510(k) clearance on 1992-02-20 under 510(k) number K915315. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AAP BONE PLATE?

AAP BONE PLATE is a medical device that received FDA 510(k) clearance on 1992-02-20. The listed applicant is Aap International, Ltd.. The 510(k) number is K915315.

When did AAP BONE PLATE receive FDA 510(k) clearance?

AAP BONE PLATE received FDA 510(k) clearance on 1992-02-20, under 510(k) number K915315.

Who is the listed applicant for AAP BONE PLATE?

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

What is the FDA product code for AAP BONE PLATE?

The FDA product code for AAP BONE PLATE is HRS.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Aap International, Ltd. 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.

K915316AAP BONE SCREW

Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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