FDA.reportPublic FDA data

Streamline MIS Spinal Fixation System

Primary DI
00191083017310
Brand
Streamline MIS Spinal Fixation System
Company
Xtant Medical Holdings, Inc.
Model
724-416
Catalog number
724-416
Device description
GENERAL SPINE CANNULATED FASCIA CHISEL
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
FZOCHISEL, SURGICAL, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZOChisel, Surgical, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191083017310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191083017310001910830173101910830173100191083017310

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chisel bladeA device that is an interchangeable component of an orthopaedic chisel and functions as the cutting blade which is attached and locked to a dedicated handle. Together, they become a single-blade surgical instrument, bevelled on one side, intended to cut or contour bone. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design and is typically made of high-grade stainless steel. This is a reusable device.

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
081224143
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840311258635C-Plus PEEK IBF System724-729724-7292026-08-26
00191083026664C-Plus PEEK IBF System724-729724-7292020-09-25
00840311211470Streamline TL Spinal Fixation System724-279724-2792026-07-30
00840311264032Cortera Spinal Fixation System1509-1300401509-1300402026-07-20
M697X07900081Silex Sacroiliac Joint Fusion SystemX079-00082026-07-08
M697X07900671Silex Sacroiliac Joint Fusion SystemX079-00672026-07-08
M697X07901121Silex Sacroiliac Joint Fusion SystemX079-01122026-07-08
M697X07901151Silex Sacroiliac Joint Fusion SystemX079-01152026-07-08
00849777014052Union DBM, 1cc11-0001-0012026-06-24
00849777014069Union DBM, 2.5cc11-0001-0022026-06-24
00849777014076Union DBM, 5cc11-0001-0052026-06-24
00849777014083Union DBM, 10cc11-0001-0102026-06-24
00810076560007BiomaXBMX-00012021-11-02
00810076560380BiomaXBMX-00022021-11-02
00810076560649BiomaXBMX-00052021-11-02
00810076560656BiomaXBMX-00102021-11-02
00810076560663BiomaXBMX-01012021-11-02
00810076560670BiomaXBMX-01022021-11-02
00810076560687BiomaXBMX-01052021-11-02
00810076560694BiomaXBMX-01102021-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054896001753ChiselSilony Medical GmbHFZO2026-09-18
04054896001760ChiselSilony Medical GmbHFZO2026-09-18
04054896001777ChiselSilony Medical GmbHFZO2026-09-18
04054896005751ChiselSilony Medical GmbHFZO2026-09-18
04054896018430ChiselSilony Medical GmbHFZO2026-09-18
04054896018447ChiselSilony Medical GmbHFZO2026-09-18
04054896050652ChiselSilony Medical GmbHFZO2026-09-18
04054896050669ChiselSilony Medical GmbHFZO2026-09-18
04054896050676ChiselSilony Medical GmbHFZO2026-09-18
04054896050683ChiselSilony Medical GmbHFZO2026-09-18
04054896050690ChiselSilony Medical GmbHFZO2026-09-18
04054896050706ChiselSilony Medical GmbHFZO2026-09-18
04054896051284ChiselSilony Medical GmbHFZO2026-09-18
04054462907663evonosevonos GmbH & Co. KGFZO2026-08-21
04054462912162evonosevonos GmbH & Co. KGFZO2026-08-19
04054462912179evonosevonos GmbH & Co. KGFZO2026-08-19
04054462912803evonosevonos GmbH & Co. KGFZO2026-08-19
04054462912810evonosevonos GmbH & Co. KGFZO2026-08-19
04054462905416evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905423evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905430evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905447evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905461evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905478evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905485evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905492evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905508evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905515evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905522evonosevonos GmbH & Co. KGFZO2026-08-18
04054462907632evonosevonos GmbH & Co. KGFZO2026-08-18