FDA applicant

Alphatec Mfg., Inc.

Palm Desert, CA20 decisions1990–20041 recall

FDA records 20 decisions for Alphatec Mfg., Inc. (Palm Desert, CA) from 1990 to 2004: 20 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Its devices cite 8 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 Alphatec Mfg., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Alphatec Mfg., Inc. since 2007.

Recalls per year

1in 2010

2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Alphatec Mfg., 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 “Alphatec”

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

Alphatec Spine, Inc. 102 Alphatec/Nexmed 9

Alphatec Mfg., Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Alphatec”