FDA.reportPublic FDA data

Click'X

Primary DI
H9814985710
Brand
Click'X
Company
SYNTHES (U.S.A.) LP
Model
498.571
Catalog number
498571
Device description
TI 3-D HEAD FOR TI CLICK'X® SCREWS
Published
2015-09-14
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034791098PrimaryGS10
H9814985710SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503479109810705034791098

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw headA small, implantable, non-bioabsorbable device intended to be attached to the top end of a spinal screw (not included) typically to secure/stabilize a rod and/or connector as part of an internal spinal fixation procedure. It is typically U-shaped with threads to receive a set screw and/or has a hole to allow the rod and/or connector to pass through; it may also facilitate a degree of motion. It is made of metal (e.g., surgical steel, titanium alloy) and/or synthetic polymer materials.

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
832637081
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
10886982249210NA60.550.040605500402017-02-20
10886982239884NA530.4125304122016-12-31
10886982192172NA329.7223297222017-02-20
10886982192295LC-DCP329.9183299182017-02-20
10886982201461NA398.56398562017-02-20
10886982201478NA398.58398582017-02-20
10705034718040NA03.620.219036202192018-10-29
10705034767802VentroFix304.8323048322016-12-31
10705034775418NA389.2963892962016-12-31
10705034775425NA389.2973892972016-12-31
10705034775432NA389.2983892982016-12-31
10705034775449NA389.2993892992016-12-31
10705034798455NA690.0386900382016-12-31
10887587039893NA338.7613387612016-12-31
10886982338778MAXFRAME1100022-011100022012024-02-05
10886982338570MAXFRAME1100011-011100011012022-04-26
10886982338587MAXFRAME1100010-011100010012022-04-26
10886982338594MAXFRAME1100012-011100012012022-04-26
10886982338600MAXFRAME1100007-011100007012022-04-26
10886982237217NA510.1615101612019-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115935677XL AdaptorPREMIA SPINE LTDMNI2026-10-20
07290115935905XL Screwdriver CMPREMIA SPINE LTDMNI2026-10-20
07290115935912Screwdriver CMPREMIA SPINE LTDMNI2026-10-20
07290115935929Tube for K-wire over a k-wire technique 470mm (Nitinol)PREMIA SPINE LTDMNI2026-10-20
07290115935936Tube for XL K-Wire 450mmPREMIA SPINE LTDMNI2026-10-20
07290115935943Tube for K-Wires of 470mmPREMIA SPINE LTDMNI2026-10-20
07290115935950Tube for K-Wires up to 340mmPREMIA SPINE LTDMNI2026-10-20
07290115932874Cannulated Screwdriver inner shaftPREMIA SPINE LTDMNI2026-10-18
07290115932881Cannulated Screwdriver Handle AssyPREMIA SPINE LTDMNI2026-10-18
M697X07300251Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X073825100DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X07382560DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X07382565DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X07382570DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X07382575DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X07382580DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X07382585DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X07382590DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X07382595DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
08806364689439Kora Spinal SystemMedyssey Co., Ltd.MNI2026-10-01
08806364690077Kora Spinal SystemMedyssey Co., Ltd.MNI2026-10-01
00840916134013TALONSPINAL ELEMENTSMNI2019-03-26
00840916134020TALONSPINAL ELEMENTSMNI2019-03-26
00840916134037TALONSPINAL ELEMENTSMNI2019-03-26
10888857001428DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05