Kiscomedica S.A.
Round Rock, TX, US
Kiscomedica S.A. appears in FDA device records in Round Rock, TX. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Kiscomedica S.A. in 2008.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1461-2017 | L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). L-Varlock Lumbar implants are to be used with autogenous bone graft and implanted via an open posterior approach. L-Varlock Lumbar implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. | Firm received a complaint of the tip holder breaking during use. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain