510(k) Report

FDA applicant

Ruggles Corp.

No. Quincy, MA5 decisions1989–19911 recall

FDA records 5 decisions for Ruggles Corp. (No. Quincy, MA) from 1989 to 1991: 5 510(k) clearances. Most are in product codes HBG (Drills, Burrs, Trephines & Accessories (Manual)) and LXH (Orthopedic Manual Surgical Instrument). 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, neurology panel, where it files most

How often FDA has decided Ruggles Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ruggles Corp. since 2007.

Recalls per year

1in 2013

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

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • HBGDrills, Burrs, Trephines & Accessories (Manual)1decision
  • LXHOrthopedic Manual Surgical Instrument1decision
  • HAOInstrument, Surgical, Non-Powered1decision
  • LYQAccessories, Fixation, Spinal Intervertebral Body1decision
  • GWOPlate, Cranioplasty, Preformed, Alterable1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K902819Laminectomy RogeurRuggles Corp. · 19901cites it

What has FDA decided for it lately?

  • K903485Titanium MeshRuggles Corp. · 1991
  • K902818Multiple Nonpowered Neurosurgical InstrumentRuggles Corp. · 19901 recall
  • K902819Laminectomy RogeurRuggles Corp. · 1990
  • K902850Zeppelin InstrumentsRuggles Corp. · 1990
  • K893415Trans-Oral Depth GaugeRuggles Corp. · 1989

All 5 as Ruggles Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K902818Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The…Jul 17, 2013Class II