FDA.reportPublic FDA data

Zyfix Spinal Facet Screw System

Primary DI
M697X07600211
Brand
Zyfix Spinal Facet Screw System
Company
Xtant Medical Holdings, Inc.
Model
X076-0021
Device description
Zygafix COMPRESSION SCREW, 6.0 x 30MM DUAL THREAD
Published
2015-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRWSYSTEM, FACET SCREW SPINAL DEVICE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRWSystem, Facet Screw Spinal DeviceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123932000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123932000ZYGAFIX SPINAL FACET SCREW SYSTEMX-Spine Systems, Inc.2013-05-01MRW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697X07600211PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Trans-facet-screw internal spinal fixation system, sterileA sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Millimeter
Outer Diameter6Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(937)847-8400orders@x-spine.com
+1(888)886-9354cs@xtantmedical.com

Regulatory Flags#

DUNS number
081224143
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840311258185Fusion Lateral Instrument Set38-SLAPHAMMER2026-10-23
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
M697X07300291Xpress Minimally Invasive Pedicle Screw SystemX073-00292026-10-14
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

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