Class Class II
Pitkar Spinal Pedicle Screw System (K240233)
Description
Pitkar Spinal Pedicle Screw System by S.H.Pitkar Orthotools Pvt. , Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240233
Clearance Date2024-09-09
Clearance TypeTraditional
Product CodeNKB
Regulation Number888.3070
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240233
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Pitkar Spinal Pedicle Screw System (K240233) cites 8 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201457 | Auxein Brand Vertaux 5.5 mm Pedicle Screw System | Auxein Medical Private Limited/71164 | 2021 |
| K192619 | Pitkar Locked Plating System | S.H.Pitkar Orthotools Pvt. , Ltd. | 2020 |
| K190471 | 4CIS® Chiron Spinal Fixation System | Solco Biomedical Co., Ltd. | 2019 |
| K180226 | TREND II Spinal Fixation System- STEP Series | Paonan Biotech Co., Ltd. | 2018 |
| K090648 | VIPER 2 SYSTEM | Depuy Spine, Inc. | 2009 |
| K082572 | USS ILIOSACRAL, USS POLYAXIAL | Synthes Spine | 2008 |
| K060648 | REPROCESSED PHACOEMULSIFICATION TIPS | Alliance Medical Corp. | 2007 |
| K043578 | THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM | Solco Biomedical Co., Ltd. | 2005 |
Trace the full predicate network for K240233
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.