FDA.reportPublic FDA data

Fortilink-TS IBF System

Primary DI
00191083008714
Brand
Fortilink-TS IBF System
Company
Pioneer Surgical Technology, Inc.
Model
65-TS-15-32
Catalog number
65-TS-15-32
Device description
Interbody Fusion Device
Published
2021-02-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
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
K192718000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192718000Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.2019-12-20MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846468084233PreviousGS10
00191083008714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468084233008464680842338464680842330846468084233
00191083008714001910830087141910830087140191083008714

Device Sizes#

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

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
00846468049430nanOss ABGS90-100-0190-100-012015-12-14
00846468049447nanOss ABGS90-100-0290-100-022015-12-14
00846468049454nanOss ABGS90-100-0590-100-052015-12-14
00846468049461nanOss ABGS90-100-1090-100-102015-12-14
00846468049478nanOss ABGS90-100-2090-100-202015-12-14
00846468049515nanOss Loaded ABGS90-200-0590-200-052015-12-14
00846468049522nanOss Loaded ABGS90-200-1090-200-102015-12-14
00846468049546nanOss 3D ABGS90-300-2550490-300-255042015-12-14
00846468049553nanOss 3D ABGS90-300-2550890-300-255082015-12-14
00846468049560nanOss 3D ABGS90-300-25100490-300-2510042015-12-14
00846468049577nanOss 3D ABGS90-300-25100890-300-2510082015-12-14
00846468057411nanOss Loaded ABGS90-200-05K90-200-05K2015-12-14
00846468057428nanOss BA - Loaded90-200-10K90-200-10K2015-12-14
00846468087104nanOss® 3D Plus™90-400-2550490-400-255042018-09-19
00846468087111nanOss® 3D Plus™90-400-2550890-400-255082018-09-19
00846468087128nanOss® 3D Plus™90-400-25100890-400-2510082018-09-19
00846468087135nanOss® 3D Plus™90-400-25100490-400-2510042018-09-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800322691458Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691533Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691540Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691557Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691564Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691571Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691588Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691595Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691601Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861110Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861127Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861134Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861295Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861301Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861318Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861325Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861332Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861349Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861356Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861363Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861370Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861387Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861394Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861400Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861424Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861431Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861448Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861455Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861462Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861479Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19