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OSSDSIGN Cranioplug

Ossdsign AB · Model 11 mm, 6 fixation-points · UDI-DI 07350086550252

GXR Prescription

510(k) clearances

210

Adverse events

Recalls

Facilities

Description

OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanical performance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators. (510(k) no. K181539)

Recalls

Date	Firm	Reason
2021-06-02	Medtronic Neuromodulation	Excess nylon flash on the clip.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.