FDA.reportPublic FDA data

Streamline OCT Occipito-Cervico-Thoracic System

Primary DI
00846468058142
Brand
Streamline OCT Occipito-Cervico-Thoracic System
Company
Pioneer Surgical Technology, Inc.
Model
26-HA-40-34
Catalog number
26-HA-40-34
Device description
SCREW, HIGH ANGLE
Published
2020-09-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
NKGPosterior cervical screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150254000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150254000Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2015-04-28KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846468058142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468058142008464680581428464680581420846468058142

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(386)418-8888labeling@rtix.com

Regulatory Flags#

DUNS number
793384496
Device count
1
Lot or batch
true
Sterilization required before use
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
08800322693100VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693117VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693124VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693131VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693148VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693155VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
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
10888857598485Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24