MEDPOR Customized Implant Kit— 510(k) K254233
Substantially EquivalentStryker Leibinger GmbH & Co KG
FDA 510(k) clearance K254233 for MEDPOR Customized Implant Kit, Substantially Equivalent on 2026-03-12. Applicant: Stryker Leibinger GmbH & Co KG. Device class: 2.
Summary
Stryker Leibinger's MEDPOR Customized Implant Kit is filed under FWP, internal chin prostheses. The record doesn't list what the kit contains.
Class II, 21 CFR 878.3550. It was a Special 510(k), and General and Plastic Surgery is both the classification panel and the review panel.
Stryker Leibinger filed from Frieburg, Germany, as the record spells the city. The decision came 73 calendar days after FDA received it (December 29, 2025 to March 12, 2026).
Clearance details
- Applicant
- Stryker Leibinger GmbH & Co KG
- Product code
- Product code FWP
- Device class
- Class 2
- Regulation
- 21 CFR 878.3550
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Frieburg, DE
Recent devices under product code FWP
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