FDA.reportPublic FDA data

Novation Element

Primary DI
10885862280626
Brand
Novation Element
Company
Exactech, Inc.
Model
165-30-07
Catalog number
165-30-07
Device description
NV ELEMENT STARTER RASP SZ 7 WITH CHIP BREAKERS
Published
2022-08-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080980000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080980000EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMSExactech, Inc.2008-05-06MEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862280626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586228062610885862280626

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
157565946
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885862032102Novation160-20-11160-20-112015-08-10
10885862064035Optetrak244-24-09244-24-092015-10-30
10885862307132Truliant02-022-49-251102-022-49-25112017-05-16
10885862313058Optetrak Logic02-012-44-260902-012-44-26092017-02-16
10885862313065Optetrak Logic02-012-44-261102-012-44-26112017-02-16
10885862313072Optetrak Logic02-012-44-261302-012-44-26132017-02-16
10885862313089Optetrak Logic02-012-44-261502-012-44-26152017-02-16
10885862313218Optetrak Logic02-012-35-210902-012-35-21092017-02-16
10885862313225Optetrak Logic02-012-35-211102-012-35-21112017-02-16
10885862313232Optetrak Logic02-012-35-211302-012-35-21132017-02-16
10885862316271Optetrak Logic02-012-35-211702-012-35-21172017-02-16
10885862316288Optetrak Logic02-012-35-211902-012-35-21192017-02-16
10885862316356Optetrak Logic02-012-44-261702-012-44-26172017-02-16
10885862316363Optetrak Logic02-012-44-261902-012-44-26192017-02-16
10885862135049NAT2-5052T2-50522022-09-19
10885862135056NAT2-5458T2-54582022-09-19
10885862135063NAT2-6064T2-60642022-09-19
10885862135070NAT2-6670T2-66702022-09-19
10885862135636NAT8-4448T8-44482022-09-19
10885862135643NAT8-5052T8-50522022-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896466United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896473United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896480United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896497United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896503United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896510United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896527United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896534United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896541United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896558United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896565United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896572United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896589United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896596United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896633United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896640United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896657United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896664United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896671United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896688United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896695United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896701United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896718United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896725United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896732United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896749United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896756United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896763United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896770United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896787United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24