PROW FUSION-L— 510(k) K153665

Clearance details

Applicant

Nlt Spine, Ltd.

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2015-12-21

Decision date

2016-09-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Kfar-Saba, IL

• K261049 — SCALA® TL2026-08-20
• K261430 — TruLift Expandable System2026-07-28
• K253011 — Catalyft PL Expandable Interbody System2026-07-17
• K261020 — Symmetrix L Spinal System2026-07-14
• K253420 — Admiral ACP System +18 more2026-07-01

• K153786 — PROW FUSION-V2016-07-11
• K151654 — PROW FUSION2015-07-17
• K133061 — ESPIN SYSTEM2013-11-27
• K130254 — PROW FUSION2013-10-16
• K130057 — ESPIN2013-02-07

Death

13

Injury

1,305

Malfunction

2,885

Total

4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →