FDA.reportPublic FDA data

Streamline® OCT Occipito-Cervico-Thoracic System

Primary DI
00846468083588
Brand
Streamline® OCT Occipito-Cervico-Thoracic System
Company
Pioneer Surgical Technology, Inc.
Model
26-PA-35-40
Catalog number
26-PA-35-40
Device description
Pedicle Screw, Polyaxial, 3.5mm (D) X 40mm (L)
Published
2019-03-31
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
NKGOrthosis, cervical pedicle screw spinal fixation

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161498000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161498000Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2016-08-22NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846468083588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468083588008464680835888464680835880846468083588

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
+1(906)226-9909labeling@resolvesurg.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
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
00763000992316INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992323INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992330INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992347INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992453INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00840606192057Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192064Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192071Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192088Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192095Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192101Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192118Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192125Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192132Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192149Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192156Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192163Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192170Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192187Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192194Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192200Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192217Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192224Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192231Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192248Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192255Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192262Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192279Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192286Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192293Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24