FDA.reportPublic FDA data

BacFuse®

Primary DI
00846468047726
Brand
BacFuse®
Company
Pioneer Surgical Technology, Inc.
Model
83-00-12
Catalog number
83-00-12
Device description
12mm 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
00846468047726PrimaryGS10
00846468091989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468047726008464680477268464680477260846468047726
00846468091989008464680919898464680919890846468091989

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
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
00193982239862CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239886CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239909CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239923CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239947CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239961CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982240240CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982240363CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982240622CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450151CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450168CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450175CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450182CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450199CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521134QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521141QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521158QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521165QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521172QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521189QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521196QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521202QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521219QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521226QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521233QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521240QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521257QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521264QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521271QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982669638CREOGLOBUS MEDICAL, INC.KWP2026-08-14