FDA.reportPublic FDA data

NOVAE

Primary DI
03662200012985
Brand
NOVAE
Company
SOC ETUDES RECHERCHES FABRICATION
Model
ET
Published
2022-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662200012985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662200012985036622000129853662200012985

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/instrument assembling deviceA non-sterile, noninvasive tool designed to support assembly of the component parts of an orthopaedic implant or surgical instrument during an orthopaedic surgical procedure, typically when component sizes are determined during the procedure [e.g., stem, neck, and head femoral components of a total hip arthroplasty (THA)]. It is available in one of a variety of forms (e.g., holder, clamp/press), however it is not a component of the final instrument/implant and is not a surgical screwdriver or wrench. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
282651413
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03662200033126Trays associated with hip instrumentsRA999900622024-09-17
03662200005796CI ECI 41/22,2 E2015-09-01
03662200005802CI ECI 43/22,2 E2015-09-01
03662200005819CI ECI 45/22,2 E2015-09-01
03662200005826CI ECI 47/22,2 E2015-09-01
03662200005833CI ECI 49/22,2 E2015-09-01
03662200005840CI ECI 51/22,2 E2015-09-01
03662200005857CI ECI 53/22,2 E2015-09-01
03662200005864CI ECI 55/22,2 E2015-09-01
03662200005871CI ECI 57/22,2 E2015-09-01
03662200005888CI ECI 59/22,2 E2015-09-01
03662200005895CI ECI 61/22,2 E2015-09-01
03662200005901CI ECI 63/22,2 E2015-09-01
03662200005918CI ECI 65/22,2 E2015-09-01
03662200005925CI ECI 67/22,2 E2015-09-01
03662200005932CI ECI 69/22,2 E2015-09-01
03662200005963CI ECI 47/28 E2015-09-01
03662200005970CI ECI 49/28 E2015-09-01
03662200005987CI ECI 51/28 E2015-09-01
03662200005994CI ECI 53/28 E2015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000777623MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-25
00763000786434MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-25
00763000777616CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-23
00850078396297TruPWR Torque Limiting Attachment Sterile, Single Use 90 in-lbEca Medical InstrumentsHWE2026-10-20
00850078396365PFT Adapter, DS, Mariner,105 in-lb (228-TXRX-009)Eca Medical InstrumentsHWE2026-10-20
00850078396372PFT Adapter, DS, Virata, 85 in-lb (228-TXRX-008)Eca Medical InstrumentsHWE2026-10-20
00889024709164CANNULATED 1.5MM HEX DRIVERZimmer, Inc.HWE2026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERZimmer, Inc.HWE2026-10-19
00810111227872PinTreace Medical Concepts, Inc.HWE2026-10-16
00763000786458CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-15
00810111228541Drill TackTreace Medical Concepts, Inc.HWE2026-10-15
00810111227971PinTreace Medical Concepts, Inc.HWE2026-10-12
00810111227988PinTreace Medical Concepts, Inc.HWE2026-10-12
03700879515687Airlock®NOVASTEPHWE2026-08-25
08800038061286EZXIMEDICOM CO., LTD.HWE2026-08-25
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00850083430122SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
00850083430139SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
10888857596719Xia® 3VB Spine LLCHWE2026-05-12
10888857596726Xia® 3VB Spine LLCHWE2026-05-12
10888857596733Xia® 3VB Spine LLCHWE2026-05-12
10888857578135Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578142Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578159Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578166Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578210Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578227Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578234Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578241Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20