Atlas FDA

Kalitec Direct InSePtion™ MIS Fixation System

FDA 510(k) clearance K163471 · decided 2017-03-16

Clearance details

K-number
K163471
Device name
Kalitec Direct InSePtion™ MIS Fixation System
Applicant
Kalitec Direct, LLC
Decision
Substantially Equivalent
Date received
2016-12-12
Decision date
2017-03-16
Days to decision
94 days
Clearance type
Traditional
Product code
PEK
Device class
2
Regulation number
888.3050
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Orlando, FL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Kalitec Direct

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Minuteman® G6 MIS Fusion Plate (K253250)Spinal Simplicity, LLC2025-12-01
Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 (K234051)Spinal Simplicity, LLC2024-01-18
Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate (K233527)Spinal Simplicity, LLC2023-11-29
KeyLift™ Expandable Interlaminar Stabilization System (K232484)Amplio Spine, LLC2023-10-19
primaLOK™ SP Interspinous Fusion System (K231807)Wenzel Spine, Inc.2023-08-15
Huvex Interspinous Fusion System (K223790)Dio Medical Corp.2023-03-09
Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 (K221023)Spinal Simplicity, LLC2022-08-19
ZIP™ MIS Interspinous Fusion System (K221399)Aurora Spine, Inc.2022-07-08
Minuteman G5 MIS Fusion Plate (K211880)Spinal Simplicity, LLC2022-03-11
Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate (K212781)Spinal Simplicity, LLC2021-12-15
Inspan ScrewLES Fusion System (K213266)Lespine Innovations, LLC2021-12-03
Posterior Fusion Plate, HA Posterior Fusion Plate (K200066)Spinal Simplicity, LLC2020-12-10

Recalls involving this device

No recalls on record reference this clearance.