HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT— 510(k) K924935

Name: FDA 510(k) clearance K924935
Creator: U.S. Food and Drug Administration
Published: 1993-09-02

Substantially Equivalent

Polyclinic Medical Center

FDA 510(k) clearance K924935 for HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT, Substantially Equivalent on 1993-09-02. Applicant: Polyclinic Medical Center. Device class: 2.

Clearance details

Applicant: Polyclinic Medical Center
Product code: Code KKY
Device class: Class 2
Regulation: 21 CFR 878.3500
Advisory panel: General, Plastic Surgery
Date received: 1992-09-30
Decision date: 1993-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K924935

K-number listed on FDA's recall record

Z-2751-2016 — Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.Class II·Terminated·Biomet Microfixation, LLC·20160613

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K924935.

Data sourced from openFDA. This site is unofficial and independent of the FDA.