FDA.reportPublic FDA data

NA

Primary DI
10886982313676
Brand
NA
Company
Synthes GmbH
Model
SD03.037.033
Catalog number
SD03037033
Device description
TFNA BROKEN NAIL EXTRACTOR
Published
2022-04-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131548000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131548000SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEMSynthes (USA) Products, LLC2014-02-28HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982313676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698231367610886982313676

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982342508VOLT02.535.724025357242026-09-25
10886982342515VOLT02.535.726025357262026-09-25
10886982342522VOLT02.535.728025357282026-09-25
10886982342539VOLT02.535.730025357302026-09-25
10886982342546VOLT02.535.732025357322026-09-25
10886982342553VOLT02.535.734025357342026-09-25
10886982342560VOLT02.535.736025357362026-09-25
10886982342577VOLT02.535.738025357382026-09-25
10886982342584VOLT02.535.740025357402026-09-25
10886982342591VOLT02.535.742025357422026-09-25
10886982342607VOLT02.535.744025357442026-09-25
10886982342614VOLT02.535.746025357462026-09-25
10886982342621VOLT02.535.748025357482026-09-25
10886982342638VOLT02.535.750025357502026-09-25
10886982342645VOLT02.535.752025357522026-09-25
10886982342652VOLT02.535.754025357542026-09-25
10886982342669VOLT02.535.756025357562026-09-25
10886982342676VOLT02.535.758025357582026-09-25
10886982342683VOLT02.535.760025357602026-09-25
10886982344878VOLT02.535.765025357652026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982471415AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471439AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471453AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471477AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471491AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471514AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471538AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471767AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471781AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471804AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471828AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471842AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471866AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471880AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472115AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472139AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472153AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472177AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472191AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472214AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472238AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473822AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473846AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473860AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473884AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473907AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473921AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473945AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982474171AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982474195AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14