FDA.reportPublic FDA data

XIPHOS ZFUZE

Primary DI
00853896008052
Brand
XIPHOS ZFUZE
Company
Difusion Technologies, Inc.
Model
ZF-100-2213
Catalog number
ZF-100-2213
Device description
PLIF Spacer 22mm Long x 13mm Height
Published
2020-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190544000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190544000XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies2019-11-01MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853896008052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853896008052008538960080528538960080520853896008052

GMDN Terms#

Term, Definition table
TermDefinition
Interspinous spinal fixation implantAn implantable device intended to be attached to two adjacent vertebral spinous processes to provide immobilization and stabilization of spinal segments as an adjunct to bony fusion in the treatment of spinal conditions (e.g., degenerative disc disease, spondylolisthesis, tumour, trauma). It is intended to be used on the thoracic, lumbar or sacral spine during a minimally-invasive procedure. It is made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and may incorporate bone graft pockets. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
512-284-4440customerservice@difusiontech.com

Regulatory Flags#

DUNS number
022051967
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853896008007XIPHOS ZFUZEZF-100-2211ZF-100-22112020-02-21
00853896008014XIPHOS ZFUZEZF-100-2208ZF-100-22082020-02-21
00853896008021XIPHOS ZFUZEZF-100-2209ZF-100-22092020-02-21
00853896008038XIPHOS ZFUZEZF-100-2210ZF-100-22102020-02-21
00853896008045XIPHOS ZFUZEZF-100-2212ZF-100-22122020-02-21
00853896008069XIPHOS ZFUZEZF-100-2214ZF-100-22142020-02-21
00853896008076XIPHOS ZFUZEZF-100-2608ZF-100-26082020-02-21
00853896008083XIPHOS ZFUZEZF-100-2609ZF-100-26092020-02-21
00853896008090XIPHOS ZFUZEZF-100-2610ZF-100-26102020-02-21
00853896008106XIPHOS ZFUZEZF-100-2611ZF-100-26112020-02-21
00853896008113XIPHOS ZFUZEZF-100-2612ZF-100-26122020-02-21
00853896008120XIPHOS ZFUZEZF-100-2613ZF-100-26132020-02-21
00853896008137XIPHOS ZFUZEZF-100-2614ZF-100-26142020-02-21
00853896008144XIPHOS ZFUZEZF-100-2908ZF-100-29082020-02-21
00853896008151XIPHOS ZFUZEZF-100-2909ZF-100-29092020-02-21
00853896008168XIPHOS ZFUZEZF-100-2910ZF-100-29102020-02-21
00853896008175XIPHOS ZFUZEZF-100-2911ZF-100-29112020-02-21
00853896008199XIPHOS ZFUZEZF-100-2913ZF-100-29132020-02-21
00853896008205XIPHOS ZFUZEZF-100-2914ZF-100-29142020-02-21
00853896008212XIPHOS ZFUZEZF-300-2408ZF-300-24082020-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000881153MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881382MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881399MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881405MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
18257200076871FORZAOrthofix US LLCMAX2026-07-17
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18257200136056FORZA XPOrthofix US LLCMAX2026-07-17
18257200136063FORZA XPOrthofix US LLCMAX2026-07-17
18257200136070FORZA XPOrthofix US LLCMAX2026-07-17
18257200151769FORZA TiOrthofix US LLCMAX2026-07-17