NEXFIX COMPRESSION STAPLE— 510(k) K070688

Name: FDA 510(k) clearance K070688
Creator: U.S. Food and Drug Administration
Published: 2007-05-18

Substantially Equivalent

Nexa Orthopedics, Inc.

FDA 510(k) clearance K070688 for NEXFIX COMPRESSION STAPLE, Substantially Equivalent on 2007-05-18. Applicant: Nexa Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Nexa Orthopedics, Inc.
Product code: Code JDR
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2007-03-12
Decision date: 2007-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDR

view all

K262451 — Arthrex DynaNite Staples2026-09-01
K261121 — Megalodon Dynamic Compression System2026-08-06
K250712 — Linkt Compression Staple System2025-05-14
K243888 — Medline UNITE® REFLEX® Hybrid Nitinol Implant System2025-04-11
K243742 — Arthrex DynaNite Nitinol Staples2025-01-31

More clearances from Nexa Orthopedics, Inc.

view all

K072710 — NEXFIX COMPRESSION PIN2007-11-08
K071147 — NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM2007-07-20
K060386 — NEXA CARPO METACARPAL IMPLANT2006-05-10
K060071 — NEXA COMPRESSION SCREW2006-01-26
K053408 — NEXA BONE PLATE AND SCREW SYSTEM2005-12-22

Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.