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Wishbone HAE (K260096): 510(k) cleared for Wishbone SA vs CMF Titanium Splints (K260913): 510(k) cleared for Materialise NV: FDAPulse comparison
Wishbone HAE (K260096): 510(k) cleared for Wishbone SA's review days of 269 is 1.3x CMF Titanium Splints (K260913): 510(k) cleared for Materialise NV's 204 (93rd percentile). Wishbone HAE (K260096): 510(k) cleared for Wishbone SA is dated 2026-10-09; CMF Titanium Splints (K260913): 510(k) cleared for Materialise NV 2026-10-09.
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe
How does Wishbone HAE (K260096): 510(k) cleared for Wishbone SA compare to CMF Titanium Splints (K260913): 510(k) cleared for Materialise NV?
| Field | Wishbone HAE (K260096): 510(k) cleared for Wishbone SA | CMF Titanium Splints (K260913): 510(k) cleared for Materialise NV |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K260096 | K260913 |
| Device | Wishbone HAE | CMF Titanium Splints |
| Applicant | Wishbone SA | Materialise NV |
| Specialty / panel | Dental | Dental |
| Product code | NPM | DZJ |
| Device class | 2 | 2 |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2026-01-13 | 2026-03-19 |
| Decision date | 2026-10-09 | 2026-10-09 |
| Review time (days) | 269 | 204 |
| Third-party review | No | No |
| Applicant location | Flémalle, BE | Leuven, BE |
| amount percentile | 93rd | 68th |
| Predicate Speed & CAPA Advisory Opportunity Score | 61/100 | 48/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: Wishbone HAE (K260096): 510(k) cleared for Wishbone SA · CMF Titanium Splints (K260913): 510(k) cleared for Materialise NV
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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.
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