Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
New Deal, S.A. · Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
88 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063820 | LISFRANC PLATE | New Deal, S.A. | 2007-02-08 | 44 | 0 |
| K070160 | MODIFICATION TO TTC PLATES | New Deal, S.A. | 2007-02-08 | 22 | 0 |
| K070241 | MODIFICATION TO LAPIDUS PLATE | New Deal, S.A. | 2007-02-08 | 14 | 1 |
| K060474 | LISFRANC PLATE | New Deal, S.A. | 2006-08-03 | 161 | 0 |
| K061765 | KALIX II IMPLANT | New Deal, S.A. | 2006-07-18 | 26 | 0 |
| K061594 | LARGE UNI-CLIP STAPLE | New Deal, S.A. | 2006-07-03 | 25 | 0 |
| K060476 | LAPIDUS PLATE | New Deal, S.A. | 2006-05-17 | 83 | 0 |
| K060473 | TTC PLATE | New Deal, S.A. | 2006-05-17 | 83 | 0 |
| K053093 | KALIX II IMPLANT, MODEL 141 0XX WITH XX | New Deal, S.A. | 2005-12-07 | 34 | 0 |
| K052152 | B-BOP PLATE | New Deal, S.A. | 2005-09-13 | 36 | 0 |
| K050882 | NEWDEAL ANKLE NAIL | New Deal, S.A. | 2005-05-27 | 50 | 4 |
| K050346 | STABILIZATION SCREW | New Deal, S.A. | 2005-03-17 | 34 | 4 |
| K041786 | CALCAMEA PLATE | New Deal, S.A. | 2004-09-08 | 69 | 0 |
| K022597 | K-FIX | New Deal, S.A. | 2002-11-01 | 88 | 0 |
| K022599 | NEWDEAL K WIRE | New Deal, S.A. | 2002-10-30 | 86 | 0 |
| K021626 | HALLU PLATES | New Deal, S.A. | 2002-08-12 | 87 | 0 |
| K011821 | MODIFICATION TO THE I.C.O.S SCREW | New Deal, S.A. | 2001-09-06 | 87 | 0 |
| K011875 | MODIFICATION TO THE TAC' PIN | New Deal, S.A. | 2001-09-06 | 83 | 0 |
| K011716 | THE UNI-CLIP STAPLE | New Deal, S.A. | 2001-08-30 | 87 | 0 |
| K011946 | THE SPIN SNAP-OFF SCREW | New Deal, S.A. | 2001-08-24 | 64 | 0 |
| K011262 | MODIFICATION TO THE BOLD SCREW | New Deal, S.A. | 2001-06-15 | 51 | 0 |
| K001231 | THE KALIX IMPLANT | New Deal, S.A. | 2000-07-11 | 85 | 0 |
| K993762 | I.CO.S SCREW | New Deal, S.A. | 2000-02-04 | 88 | 0 |
| K993910 | TAC' PIN | New Deal, S.A. | 2000-02-01 | 76 | 0 |
| K991566 | SOLUSTAPLE | New Deal, S.A. | 1999-08-03 | 90 | 0 |
| K991477 | SPIN SNAP-OFF SCREW | New Deal, S.A. | 1999-07-14 | 77 | 0 |
| K991482 | UNI-CLIP STAPLE | New Deal, S.A. | 1999-06-03 | 36 | 0 |
| K990622 | BOLD SCREW | New Deal, S.A. | 1999-04-29 | 63 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda