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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-38/
- Published: 2022-02-13T12:00:00.000Z
- Updated: 2026-09-14T17:32:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139591

**DEVICES**

FDA has cleared a **Spinal Resources** 510(k) for its Swedge Pedicle Screw System. The device offers cobalt-chromium and titanium tulips, double lead and cortical cancellous threads; polyaxial, monoaxial, reduction and iliac screws, and minimally invasive spinal surgery options, according to the company. Currently, it is cleared for a 5.5mm rod; 4.75mm and 5.0mm rods are pending clearance.

FDA has cleared an **OmniLife Science** 510(k) for its proprietary robotic tissue balancing device for use with the company’s OmniBotics robotic-assisted total knee replacement technology platform. The device is intended to provide surgeons with a quantitative tool to actively manage the soft tissue envelope with real-time feedback, according to the company.

FDA has cleared an **eNeura** 510(k) for its Spring TMS, indicated for the acute and prophylactic treatment of migraine headache. The prescription-only device uses single-pulse transcranial magnetic stimulation to induce a mild electric current that modulates nerve cells in the brain, according to the company.

**DRUGS**

FDA has approved **Pfizer**’s Mylotarg (gemtuzumab ozogamicin) for treating adults with newly diagnosed acute myeloid leukemia (AML) whose tumors express the CD33 antigen (CD33-positive AML). Mylotarg was originally approved under FDA’s accelerated approval program in 2000 for use as a single agent in patients with CD33-positive AML who had experienced their first relapse and were age 60 or older. The drug was voluntarily withdrawn by Pfizer in 2010 after a confirmatory Phase 3 trial did not show a clinical benefit for its use as a single agent in patients with CD33-positive AML, and the rate of fatalities as a result of treatment-related toxicity was significantly higher in the Mylotarg arm of the trial.