FDA.reportPublic FDA data

Xpress Minimally Invasive Pedicle Screw System

Primary DI
M697X07300291
Brand
Xpress Minimally Invasive Pedicle Screw System
Company
Xtant Medical Holdings, Inc.
Model
X073-0029
Device description
SCREW CADDY, DUAL LEAD EXTENDED LENGTH SCREWS
Published
2026-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697X07300291PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-888-886-9354CS@xtantmedical.com

Regulatory Flags#

DUNS number
081224143
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M697X06402401Xpress Minimally Invasive Pedicle Screw SystemX064-02402026-10-14
M697X07300151Xpress Minimally Invasive Pedicle Screw SystemX073-00152026-10-14
M697X07300251Xpress Minimally Invasive Pedicle Screw SystemX073-00252026-10-14
M697X07300261Xpress Minimally Invasive Pedicle Screw SystemX073-00262026-10-14
M697X07300271Xpress Minimally Invasive Pedicle Screw SystemX073-00272026-10-14
M697X073825100DL1Xpress Minimally Invasive Pedicle Screw SystemX073-825100-DL2026-10-14
M697X07382560DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82560-DL2026-10-14
M697X07382565DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82565-DL2026-10-14
M697X07382570DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82570-DL2026-10-14
M697X07382575DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82575-DL2026-10-14
M697X07382580DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82580-DL2026-10-14
M697X07382585DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82585-DL2026-10-14
M697X07382590DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82590-DL2026-10-14
M697X07382595DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82595-DL2026-10-14
00849777014144Vesuvius Flowable DBM, 1cc4104-K5010DP2026-09-14
00849777014151Vesuvius Flowable DBM, 2.5cc4104-K5025DP2026-09-14
00849777014168Vesuvius Flowable DBM, 5cc4104-K5050DP2026-09-14
00849777014175Vesuvius Flowable DBM, 10cc4104-K5100DP2026-09-14
00849777014182Vesuvius Flowable DBM, 0.5cc4104-K5005DP2026-09-14
00849777014052Union DBM, 1cc11-0001-0012026-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810161901791EARP, IMPLANT LID 22X50RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-15
M697X07300151Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.LRP2026-10-14
M697X07300261Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.LRP2026-10-14
M697X07300271Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.LRP2026-10-14
10198956603554CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-13
10198956612822CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-13
10198956618688CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-13
10198956578487CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956580961CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956591578CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956595576CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956604506CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956604551CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956604568CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956605732CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956605848CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956605855CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956606807CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956607668CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608351CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608900CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608924CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608931CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608948CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608955CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956609341CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956610651CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
G141588225750Carnegie Surgical LLCCarnegie Surgical LLCLRP2026-10-07
00810017915293Saber-XA, Trial CaddyELEVATION SPINE, INC.LRP2026-10-06
00810017915309SABER-XA, Screw CaddyELEVATION SPINE, INC.LRP2026-10-06