Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LINK SMALL BONE PLATES

K-Number: K854825 · 1986-01-21

ApplicantLink America, Inc.
Decision Date1986-01-21
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINK SMALL BONE PLATES is the device name listed in this FDA 510(k) record. The listed applicant is Link America, Inc.. It received FDA 510(k) clearance on 1986-01-21 under 510(k) number K854825. 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 LINK SMALL BONE PLATES?

LINK SMALL BONE PLATES is a medical device that received FDA 510(k) clearance on 1986-01-21. The listed applicant is Link America, Inc.. The 510(k) number is K854825.

When did LINK SMALL BONE PLATES receive FDA 510(k) clearance?

LINK SMALL BONE PLATES received FDA 510(k) clearance on 1986-01-21, under 510(k) number K854825.

Who is the listed applicant for LINK SMALL BONE PLATES?

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

What is the FDA product code for LINK SMALL BONE PLATES?

The FDA product code for LINK SMALL BONE PLATES 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 Link America, Inc. 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.

K972760LINK, ACETABULAR REVISION MESH CUPK964458ELLIS EXTERNAL MINI-FIXATOR SYSTEMK955296LINK MP RECONSTRUCTION HIPK954186SLED UNICOMPARTMENT KNEE SYSTEMK931571LINK CERAMIC HEADS 12/14 X 32MMK931572LINK CERAMIC HEADS 14/16 X 32MM

View all 21 devices →

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

View on FDA Database →

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

↑