Wishbone HAE— 510(k) K260096
Substantially EquivalentWishbone SA
FDA 510(k) clearance K260096 for Wishbone HAE, Substantially Equivalent on 2026-10-09. Applicant: Wishbone SA. Device class: 2.
Summary
Wishbone HAE is a bone grafting material from Wishbone SA, filed under NPM, bone grafting material of animal source. The record doesn't say which animal source is used or what "HAE" stands for.
It's Class II under 21 CFR 872.3930, and the Dental panel reviewed it as a Traditional 510(k).
Wishbone filed from Flémalle, Belgium. The review clock ran 269 days, from January 13 to October 9, 2026.
Clearance details
- Applicant
- Wishbone SA
- Product code
- Product code NPM
- Device class
- Class 2
- Regulation
- 21 CFR 872.3930
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Flémalle, BE
Recent devices under product code NPM
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