FDA.reportPublic FDA data

CONTACT™* IBF PEEK VBR/IBF SYSTEM

Primary DI
00846468036331
Brand
CONTACT™* IBF PEEK VBR/IBF SYSTEM
Company
Pioneer Surgical Technology, Inc.
Model
34-A36-20-12
Catalog number
34-A36-20-12
Device description
INTERBODY FUSION DEVICE / VERTEBRAL SPACER
Published
2016-06-25
Public version status
Update
Distribution status
Not 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
MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE
ODPIntervertebral fusion device with bone graft, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133455000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133455000CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTICPioneer Surgical Technology, Inc.2014-03-27MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846468036331PrimaryGS10
00846468091262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468036331008464680363318464680363310846468036331
00846468091262008464680912628464680912620846468091262

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal fusion cage, sterileA sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(386)418-8888labeling@rtix.com
+1(906)226-9909labeling@resolvesurg.com
+1(906)226-9909regulatory@exalta.com

Regulatory Flags#

DUNS number
793384496
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840298703685CODA™ Anterior Cervical Plate System58-202230010S2022-30-010S2023-06-28
00840298703708CODA™ Anterior Cervical Plate System58-202230014S2022-30-014S2023-06-28
00840298701445CODA™ Anterior Cervical Plate System58-102201010S1022-01-010S2023-06-26
00840298701452CODA™ Anterior Cervical Plate System58-102201012S1022-01-012S2023-06-26
00840298701469CODA™ Anterior Cervical Plate System58-102201014S1022-01-014S2023-06-26
00840298701476CODA™ Anterior Cervical Plate System58-102201016S1022-01-016S2023-06-26
00840298701490CODA™ Anterior Cervical Plate System58-102201020S1022-01-020S2023-06-26
00840298701506CODA™ Anterior Cervical Plate System58-102201022S1022-01-022S2023-06-26
00840298701520CODA™ Anterior Cervical Plate System58-102201026S1022-01-026S2023-06-26
00840298701537CODA™ Anterior Cervical Plate System58-102201028S1022-01-028S2023-06-26
00840298701544CODA™ Anterior Cervical Plate System58-102201030S1022-01-030S2023-06-26
00840298701568CODA™ Anterior Cervical Plate System58-102202026S1022-02-026S2023-06-26
00840298701582CODA™ Anterior Cervical Plate System58-102202030S1022-02-030S2023-06-26
00840298701599CODA™ Anterior Cervical Plate System58-102202032S1022-02-032S2023-06-26
00840298701605CODA™ Anterior Cervical Plate System58-102202034S1022-02-034S2023-06-26
00840298701612CODA™ Anterior Cervical Plate System58-102202036S1022-02-036S2023-06-26
00840298701629CODA™ Anterior Cervical Plate System58-102202038S1022-02-038S2023-06-26
00840298701636CODA™ Anterior Cervical Plate System58-102202040S1022-02-040S2023-06-26
00840298701643CODA™ Anterior Cervical Plate System58-102202042S1022-02-042S2023-06-26
00840298701650CODA™ Anterior Cervical Plate System58-102202044S1022-02-044S2023-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M719GLL100QC03DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-07-14
M719GLL101QC03DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-07-14
M719GLL106QC03DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-07-14
M719GLL107QC03DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-07-14
00763000857820T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-26
00763000858001T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-26
00810017913893Saber-C Body (PT), 14x17x6 6 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017913909Saber-C Body (PT), 14x17x7 6 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017913916Saber-C Body (PT), 14x17x8 6 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017913923Saber-C Body (PT), 14x17x9 6 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914357Saber-C Plate, 12x15x5 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914364Saber-C Plate, 12x15x6 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914371Saber-C Plate, 12x15x7 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914388Saber-C Plate, 12x15x8 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914395Saber-C Plate, 12x15x9 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914401Saber-C Plate, 12x15x10 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914630Saber-C Plate, 14x17x9 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00887517729545TLXNuvasive, Inc.MAX2026-04-25
00887517729576TLXNuvasive, Inc.MAX2026-04-25
00887517729620TLXNuvasive, Inc.MAX2026-04-25
00887517729644TLXNuvasive, Inc.MAX2026-04-25
00887517729705TLXNuvasive, Inc.MAX2026-04-25
00887517729767TLXNuvasive, Inc.MAX2026-04-25
00887517729781TLXNuvasive, Inc.MAX2026-04-25
00887517824912TLXNuvasive, Inc.MAX2026-04-25
00887517824929TLXNuvasive, Inc.MAX2026-04-25
00887517824967TLXNuvasive, Inc.MAX2026-04-25
00887517825018TLXNuvasive, Inc.MAX2026-04-25
00887517825025TLXNuvasive, Inc.MAX2026-04-25
00887517825063TLXNuvasive, Inc.MAX2026-04-25