Surgicraft , Ltd.: FDA clearances and approvals
Surgicraft , Ltd. has 10 FDA 510(k) clearances (first 1997, latest 2011), across 8 product codes in 2 review panels. Median 510(k) review time: 164 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 | 2 |
| MQP | Spinal Vertebral Body Replacement Device | 2 | 2 |
| FTL | Mesh, Surgical, Polymeric | 1 | 1 |
| HTN | Washer, Bolt Nut | 1 | 1 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
Review panels
Most recent Surgicraft , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091207 | SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE | HTN | 2011-02-15 | 662 |
| K072370 | SURGICRAFT SURGICAL MESH SYSTEM | FTL | 2008-07-24 | 336 |
| K080447 | SURGICRAFT SCREW FIXATION SYSTEM | MBI | 2008-06-13 | 115 |
| K073109 | STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM | OVD | 2008-06-04 | 215 |
| K072415 | STALIF (TM) C | OVE | 2008-01-25 | 150 |
| K051027 | STALIF TT | MQP | 2005-06-29 | 68 |
| K041617 | STALIF TT | MQP | 2004-09-08 | 85 |
| K991662 | TITANIUM HARTSHILL SYSTEM | KWP | 1999-11-08 | 178 |
| K982719 | THE BONE TIE | HTY | 1998-09-25 | 52 |
| K965221 | RANSFORD CERVICAL FIXATION SYSTEM | KWP | 1997-08-07 | 219 |
Recalls
openFDA lists no recalls under a recalling firm named Surgicraft , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Surgicraft , Ltd. have?
Surgicraft , Ltd. has 10 FDA 510(k) clearances (first 1997, latest 2011), across 8 product codes in 2 review panels.
How long does FDA take to clear Surgicraft , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Surgicraft , Ltd.'s cleared 510(k)s is 164 days.
What devices does Surgicraft , Ltd. make?
Its most frequent FDA product codes are KWP (Appliance, Fixation, Spinal Interlaminal, 2); MQP (Spinal Vertebral Body Replacement Device, 2); FTL (Mesh, Surgical, Polymeric, 1).
Has Surgicraft , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Surgicraft , Ltd. Related entities may recall under other names.
Next steps
- See all 10 Surgicraft , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KWP, Surgicraft , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.