PROTHESIS, CHIN, INTERNAL— 510(k) K952709

Name: FDA 510(k) clearance K952709
Creator: U.S. Food and Drug Administration
Published: 1995-08-28

Substantially Equivalent

Spirit Ridge Technologies

FDA 510(k) clearance K952709 for PROTHESIS, CHIN, INTERNAL, Substantially Equivalent on 1995-08-28. Applicant: Spirit Ridge Technologies. Device class: 2.

Clearance details

Applicant: Spirit Ridge Technologies
Product code: Code FZE
Device class: Class 2
Regulation: 21 CFR 878.3680
Advisory panel: General, Plastic Surgery
Date received: 1995-06-14
Decision date: 1995-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FZE

view all

K241253 — Medicon Epiplating System2024-12-12
K161548 — Osseointegrated Fixtures2016-12-01
K090803 — HANSON MEDICAL FACIAL IMPLANTS2010-06-30
K090630 — NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)2009-06-02
K071018 — MONARCH NASAL IMPLANT2007-05-25

More clearances from Spirit Ridge Technologies

view all

K952705 — SPIRIT RIDGE NASAL IMPLANT1995-08-28
K952706 — SPIRIT RIDGE SILICONE CARVING BLOCK1995-08-28
K952707 — SILICONE ELASTOMER MALAR IMPLANT1995-08-28
K952708 — PECTORALIS IMPLANT1995-08-28

Adverse events under product code FZE

product code FZE

Injury: 138
Total: 138

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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