FDA.report

NA

Primary DI
H679219960
Brand
NA
Company
Synthes GmbH
Model
219.96
Catalog number
21996
Device description
NUT FOR 4.5MM CORTEX SCREWS
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HTNWASHER, BOLT NUT

Product Code Classifications

CodeDeviceSpecialtyClass
HTNWasher, Bolt NutOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10886982156259PrimaryGS10
H679219960SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088698215625910886982156259

GMDN Terms

TermDefinition
Orthopaedic bone nutA sterile profiled block made of metallic or non-metallic material that is threaded on its inside surface, and designed to securely fasten a bone fixation bolt, possibly with a washer. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags

DUNS number
486711679
Device count
1
DM exempt
false
Premarket exempt
true
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 DIBrandModelCatalogPublished
10886982350435NASD03.100.130SD031001302026-02-11
10886982350442NASD03.100.131SD031001312026-02-11
10886982350459NASD03.100.132SD031001322026-02-11
10886982350466NASD03.100.133SD031001332026-02-11
10886982351579NASD399.190SD3991902026-02-11
10886982351661NASD03.010.001SD030100012026-02-11
10886982351678NASD03.010.002SD030100022026-02-11
10886982361288NASD03.405.001SD034050012026-02-11
10886982361295NASD03.100.038SD031000382026-02-11
10887587078502NASD03.501.443SD035014432026-02-11
10887587078571NASD386.902SD3869022026-02-11
10886982351586NASD03.045.001SD030450012026-02-10
10886982351593NASD03.045.003SD030450032026-02-10
10886982362186NASD03.233.016SD032330162026-01-10
10886982362193NASD03.233.017SD032330172026-01-10
10886982362209NASD03.233.018SD032330182026-01-10
10886982362216NASD03.233.019SD032330192026-01-10
10886982361257VOLT60.529.210605292102025-12-16
H9810460002902S0NA04.600.029.02S0460002902S2019-08-20
H9810460002910S0NA04.600.029.10S0460002910S2019-08-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00888867529045Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529052Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529106Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529120Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529168Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529199Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529205Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529229Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529236Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529243Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529281Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529328Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529335Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529410Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529427Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529472Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529519Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529540Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529557Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529588Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529601Arthrex®ARTHREX, INC.HTN2026-03-16
00888867530072Arthrex®ARTHREX, INC.HTN2026-03-16
00888867530096Arthrex®ARTHREX, INC.HTN2026-03-16
00888867530195Arthrex®ARTHREX, INC.HTN2026-03-16
00888867531895Arthrex®ARTHREX, INC.HTN2026-03-16
00888867531949Arthrex®ARTHREX, INC.HTN2026-03-16
00888867531970Arthrex®ARTHREX, INC.HTN2026-03-16
00888867531987Arthrex®ARTHREX, INC.HTN2026-03-16
00888867532014Arthrex®ARTHREX, INC.HTN2026-03-16
00888867532038Arthrex®ARTHREX, INC.HTN2026-03-16