FDA.reportPublic FDA data

BacFuse®

Primary DI
00846468047719
Brand
BacFuse®
Company
Pioneer Surgical Technology, Inc.
Model
83-00-10
Catalog number
83-00-10
Device description
10mm Spinous Process Fusion Plate, Titanium-Alloy
Published
2016-01-13
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
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110367000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110367000PIONEER SPINAL PROCESS FUSION PLATEPioneer Surgical Technology, Inc.2011-03-23KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846468047719PrimaryGS10
00846468091972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468047719008464680477198464680477190846468047719
00846468091972008464680919728464680919720846468091972

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

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
00763000786458CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-10-15
M711620155550Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-09-30
M711620155600Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-09-30
M711620155650Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-09-30
M711620155700Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-09-30
M711620155750Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-09-30
M711620155800Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-09-30
10888857598256Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598263Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598270Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598287Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598294Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598300Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598317Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598324Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598331Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598348Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598355Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598362Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598379Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598386Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598393Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598409Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598416Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598423Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598430Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598447Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598454Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598461Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598478Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24