510(k) Report

FDA applicant

Kiscomedica S.A.

Round Rock, TX1 decision2008–20081 recall

FDA records 1 decision for Kiscomedica S.A. (Round Rock, TX) in 2008: 1 510(k) clearance. All are in product code MAX (Intervertebral Fusion Device With Bone Graft…). 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 Kiscomedica S.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2008high 1 (2017) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Kiscomedica S.A. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision

Who builds on its devices?

Later devices cite its devices 13 times; 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.

  • K080537L-VarlockKiscomedica S.A. · 200813cite it

What has FDA decided for it lately?

  • K080537L-VarlockKiscomedica S.A. · 20081 recall

The one decision as Kiscomedica S.A. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K080537L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France.…Jan 11, 2017Class II