Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgicraft , Ltd. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
178 daysmedian FDA review time
662 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091207 | SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE | Surgicraft , Ltd. | 2011-02-15 | 662 | 0 |
| K072370 | SURGICRAFT SURGICAL MESH SYSTEM | Surgicraft , Ltd. | 2008-07-24 | 336 | 0 |
| K080447 | SURGICRAFT SCREW FIXATION SYSTEM | Surgicraft , Ltd. | 2008-06-13 | 115 | 0 |
| K073109 | STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM | Surgicraft , Ltd. | 2008-06-04 | 215 | 0 |
| K072415 | STALIF (TM) C | Surgicraft , Ltd. | 2008-01-25 | 150 | 0 |
| K051027 | STALIF TT | Surgicraft , Ltd. | 2005-06-29 | 68 | 0 |
| K041617 | STALIF TT | Surgicraft , Ltd. | 2004-09-08 | 85 | 0 |
| K991662 | TITANIUM HARTSHILL SYSTEM | Surgicraft , Ltd. | 1999-11-08 | 178 | 0 |
| K982719 | THE BONE TIE | Surgicraft , Ltd. | 1998-09-25 | 52 | 0 |
| K965221 | RANSFORD CERVICAL FIXATION SYSTEM | Surgicraft , Ltd. | 1997-08-07 | 219 | 0 |
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