Manufacturer
K2m, Inc.Q Interbody Instruments
Country / Region:United States (US)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K252873
- Device name
- Q Interbody Instruments
- Company
- K2m, Inc.
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2025-09-10
- Decision date
- 2026-02-06
- Submission type
- Traditional
- Technology type
- Software Navigation(AI inferred)
- Clinical applications
- Spine SurgeryNavigation System
- Primary application
- Spine Surgery
- Classification source
- AI classified
Indications for Use
VB Spine Q Interbody Instruments are intended to be used as accessories to Stryker's Spine Guidance System to facilitate placement of VB Spine implants. They can be navigated instruments or non-navigated manual instruments. When navigated, VB Spine Q Interbody Instruments are specifically designed for use with Stryker's Spine Guidance Software. They are intended to be used with associated trackers and adaptors to facilitate preparation and placement of VB Spine interbody implants in accordance with the indications and contraindications of the associated VB Spine Implant System and/or Stryker's Spine Guidance System.
Intended Use
VB Spine Q Interbody Instruments are intended to be used as accessories to Stryker's Spine Guidance System to facilitate placement of VB Spine implants. They can be navigated instruments or non-navigated manual instruments. When navigated, VB Spine Q Interbody Instruments are specifically designed for use with Stryker's Spine Guidance Software. They are intended to be used with associated trackers and adaptors to facilitate preparation and placement of VB Spine interbody implants in accordance with the indications and contraindications of the associated VB Spine Implant System and/or Stryker's Spine Guidance System.
Device Description
The Q Interbody Instruments include Q Inserters and Q Interbody Trials, as well as new system components including Q Calibration Devices. The Q Interbody Instruments are intended to be used to facilitate preparation and placement of VB Spine interbody implants. These instruments are designed to be compatible with Stryker's Spine Guidance 5.3 Software.
Summary parsed at:2026-06-19 04:30:12 UTC
Predicate devices
1Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece
K252873 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K252873 as a predicate