510(k) Report

FDA applicant

Disc-O-Tech Medical Technologies, Ltd.

Washington, DC16 decisions2001–20079 recalls

FDA records 16 decisions for Disc-O-Tech Medical Technologies, Ltd. (Washington, DC) from 2001 to 2007: 16 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and HRX (Arthroscope). Its devices cite 61 predicates, 19 of them its own earlier devices. 9 recalls are 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 Disc-O-Tech Medical Technologies, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2017

2013: 72017: 1
2007high 7 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Disc-O-Tech Medical Technologies, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Disc-O-Tech Medical Technologies, Ltd.’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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