FDA.reportPublic FDA data

Streamline TL Spinal Fixation System

Primary DI
00191083024851
Brand
Streamline TL Spinal Fixation System
Company
Rti Surgical, Inc.
Model
10-55-RHC-400
Catalog number
10-55-RHC-400
Device description
ROD, HEX END
Published
2021-06-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846468001803PreviousGS10
00191083024851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468001803008464680018038464680018030846468001803
00191083024851001910830248511910830248510191083024851

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation implant/sterilization container setA collection of non-sterile, implantable components of an internal spinal fixation assembly (e.g., plates, rods, screws, connectors, and/or hooks) packaged within a reusable sterilization container (i.e., all under the same product code) to be sterilized prior to implantation. The set provides the surgeon with a selection of implants (e.g., different sizes) during surgery, whereby unused implants may be resterilised for subsequent implantation in another patient. Instruments intended to facilitate implantation may be packaged with the set. This is a reusable device which includes single-use implants.

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
117560455
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191083047676RapidEase™4564SC4564SC2023-11-03
00191083047683RapidEase™4561SC4561SC2023-11-03
00191083024554Streamline TL Spinal Fixation System10-55-PR-10010-55-PR-1002021-06-25
00191083024585Streamline TL Spinal Fixation System10-55-PR-11510-55-PR-1152021-06-25
00191083024608Streamline TL Spinal Fixation System10-55-PR-12510-55-PR-1252021-06-25
00191083024615Streamline TL Spinal Fixation System10-55-PR-13010-55-PR-1302021-06-25
00191083024639Streamline TL Spinal Fixation System10-55-PR-14010-55-PR-1402021-06-25
00191083024653Streamline TL Spinal Fixation System10-55-PR-15010-55-PR-1502021-06-25
00191083024707Streamline TL Spinal Fixation System10-55-PR-5510-55-PR-552021-06-25
00191083024745Streamline TL Spinal Fixation System10-55-PR-7510-55-PR-752021-06-25
00191083024769Streamline TL Spinal Fixation System10-55-PR-8510-55-PR-852021-06-25
00191083024776Streamline TL Spinal Fixation System10-55-PR-9010-55-PR-902021-06-25
00191083024806Streamline TL Spinal Fixation System10-55-RH-15010-55-RH-1502021-06-25
00191083024844Streamline TL Spinal Fixation System10-55-RHC-20010-55-RHC-2002021-06-25
00191083024868Streamline TL Spinal Fixation System10-55-RHC-60010-55-RHC-6002021-06-25
00191083024875Streamline TL Spinal Fixation System10-55-RR-10010-55-RR-1002021-06-25
00191083024882Streamline TL Spinal Fixation System10-55-RR-11010-55-RR-1102021-06-25
00191083024899Streamline TL Spinal Fixation System10-55-RR-3510-55-RR-352021-06-25
00191083024905Streamline TL Spinal Fixation System10-55-RR-4010-55-RR-402021-06-25
00191083024950Streamline TL Spinal Fixation System10-55-RR-9010-55-RR-902021-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157075835ZAVATION DRIVERZavation LLCNKB2026-05-27
00197157075842ZAVATION K-WIREZavation LLCNKB2026-05-27
06009699901715Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-27
06009699901722Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-27
00810088650970Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651052Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651144Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651151Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651168Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651175Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651182Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651366Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651373Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651380Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651397Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651403Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651588Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651595Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651601Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651618Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651625Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651632Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651809Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651816Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651823Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651830Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651847Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651854Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088652035Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088652042Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12