FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT— 510(k) K971047

Name: FDA 510(k) clearance K971047
Creator: U.S. Food and Drug Administration
Published: 1997-06-20

Substantially Equivalent

Nexa Orthopedics, Inc.

FDA 510(k) clearance K971047 for FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT, Substantially Equivalent on 1997-06-20. Applicant: Nexa Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Nexa Orthopedics, Inc.
Product code: Code KWD
Device class: Class 2
Regulation: 21 CFR 888.3730
Advisory panel: Orthopedic
Date received: 1997-03-21
Decision date: 1997-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWD

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K250074 — HYALEX® MTP Hemiarthroplasty Implant2026-04-03
K240268 — Accu-Joint Hemi Implant2024-02-29
K221220 — Montross Extremity Medical Hemi Implant System2023-04-19
K222964 — BioPoly Lesser Toe Hemiarthroplasty Implant2022-11-22
K201393 — restor3d MTP Implant2022-05-25

More clearances from Nexa Orthopedics, Inc.

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K072710 — NEXFIX COMPRESSION PIN2007-11-08
K071147 — NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM2007-07-20
K070688 — NEXFIX COMPRESSION STAPLE2007-05-18
K060386 — NEXA CARPO METACARPAL IMPLANT2006-05-10
K060071 — NEXA COMPRESSION SCREW2006-01-26

Adverse events under product code KWD

product code KWD

Injury: 164
Total: 164

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.