FDA.reportPublic FDA data

MIS FUSION Instruments

Primary DI
00191083028095
Brand
MIS FUSION Instruments
Company
Rti Surgical, Inc.
Model
724-613
Catalog number
724-613
Device description
MIS FUSION 17mm PARALLELOGRAM SHAVER
Published
2020-09-25
Public version status
Update
Distribution status
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
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191083028095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191083028095001910830280951910830280950191083028095

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(386)418-8888labeling@rtix.com

Regulatory Flags#

DUNS number
117560455
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
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
00191083024851Streamline TL Spinal Fixation System10-55-RHC-40010-55-RHC-4002021-06-25
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

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