510(k) Report

FDA applicant

Nexa Orthopedics, Inc.

San Diego, CA16 decisions1997–20071 recall

FDA records 16 decisions for Nexa Orthopedics, Inc. (San Diego, CA) from 1997 to 2007: 16 510(k) clearances. Most are in product codes KWH (Prosthesis, Toe, Constrained, Polymer) and HWC (Screw, Fixation, Bone). Its devices cite 28 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Nexa Orthopedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2007

2007: 3
2007high 3 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Nexa Orthopedics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nexa Orthopedics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Nexa”

FDA records each applicant name separately; these may or may not be the same firm.