FDA.reportPublic FDA data

Streamline® TL Spinal Fixation System

Primary DI
00846468077754
Brand
Streamline® TL Spinal Fixation System
Company
Pioneer Surgical Technology, Inc.
Model
02-COMPTIP-O-L
Device description
Compressor Tip
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWNINSTRUMENT, COMPRESSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846468077754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468077754008464680777548464680777540846468077754

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
793384496
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840298701902CODA™ Anterior Cervical Plate System58-2022010102022-01-0102023-01-19
00840298701971CODA™ Anterior Cervical Plate System58-2022010242022-01-0242023-01-19
00840298702039CODA™ Anterior Cervical Plate System58-2022020282022-02-0282023-01-19
00840298702268CODA™ Anterior Cervical Plate System58-2022040802022-04-0802023-01-19
00840298700134CODA™ Anterior Cervical Plate System58-202221018S2022-21-018S2023-01-19
00840298700028CODA™ Anterior Cervical Plate System58-202220014S2022-20-014S2023-01-19
00840298700110CODA™ Anterior Cervical Plate System58-202221014S2022-21-014S2023-01-19
00840298700677CODA™ Anterior Cervical Plate System58-2022302002022-30-2002023-01-24
00840298701957CODA™ Anterior Cervical Plate System58-2022010202022-01-0202023-01-19
00840298702022CODA™ Anterior Cervical Plate System58-2022020262022-02-0262023-01-19
00840298702251CODA™ Anterior Cervical Plate System58-2022040762022-04-0762023-01-19
00840298700608CODA™ Anterior Cervical Plate System58-2022222002022-22-2002023-01-24
00840298700776CODA™ Anterior Cervical Plate System58-2022100072022-10-0072023-01-25
00840298700905CODA™ Anterior Cervical Plate System58-2022207172022-20-7172023-01-19
00840298701933CODA™ Anterior Cervical Plate System58-2022010162022-01-0162023-01-19
00840298701988CODA™ Anterior Cervical Plate System58-2022010262022-01-0262023-01-19
00840298702091CODA™ Anterior Cervical Plate System58-2022020402022-02-0402023-01-19
00840298702114CODA™ Anterior Cervical Plate System58-2022020442022-02-0442023-01-19
00840298702138CODA™ Anterior Cervical Plate System58-2022030452022-03-0452023-01-19
00840298702176CODA™ Anterior Cervical Plate System58-2022030572022-03-0572023-01-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B922F005003608ACURA Stabilization SystemINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITEDHWN2026-03-11
G079C5080000140MIS Golden Isles Pedicle Screw System Intelivation, LLCHWN2026-01-30
00199150061983Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWN2026-01-15
00888480530817Telluride MIS Spinal Fixation SystemHighridge Medical, LLCHWN2026-01-13
03662663217040Telluride MIS Spinal Fixation SystemHighridge Medical, LLCHWN2026-01-13
00840180543733General InstrumentsALPHATEC SPINE, INC.HWN2025-12-31
00840180544037General InstrumentsALPHATEC SPINE, INC.HWN2025-12-31
03662663244718Vital MIS Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-18
03662663198196Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-17
00840124525061Metalogix RevolutionFUSION ORTHOPEDICS, LLCHWN2025-12-16
03662663162326Zyston Interbody Spacer SystemHighridge Medical, LLCHWN2025-12-16
03662663195850Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195867Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195928Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195935Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195942Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195959Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195966Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195973Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195980Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663196000Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663196017Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663198189Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
00888480484912Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
00888480484929Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
00888480484936Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
03662663113199Virage OCT Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
03662663125895Vital MIS Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
03662663136884Polaris 4.75 Deformity SystemHighridge Medical, LLCHWN2025-12-03
03662663136891Polaris 4.75 Deformity SystemHighridge Medical, LLCHWN2025-12-03