FDA.reportPublic FDA data

NA

Primary DI
H9814982050
Brand
NA
Company
Synthes GmbH
Model
498.205
Catalog number
498205
Device description
TI PEDICLE HOOK WITHOUT BEVEL- FRONTAL
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, spondylolisthesis spinal fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990745000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990745000MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEMSynthes Spine1999-03-30MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034789453PrimaryGS10
H9814982050SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503478945310705034789453

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

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
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
10886982312327NA68.134.011681340112026-10-16
10886982346704VOLT68.134.111681341112026-10-16
10886982346735VOLT68.134.200681342002026-10-16
10886982363282NA68.045.017680450172026-10-16
10886982363299NA68.045.018680450182026-10-16
10886982363305NA68.045.019680450192026-10-16
10886982363312NA68.045.020680450202026-10-16
10705034753690ChronOS07.801.100.99S0780110099S2015-09-14
10705034753706ChronOS07.801.101.99S0780110199S2015-09-14
10705034753713ChronOS07.801.110.99S0780111099S2015-09-14
10705034753720ChronOS07.801.111.99S0780111199S2015-09-14
10705034753737ChronOS07.801.200.99S0780120099S2015-09-14
10705034799933ChronOS710.002.99S71000299S2015-09-14
10705034799940ChronOS710.014.99S71001499S2015-09-14
10705034799957ChronOS710.019.99S71001999S2015-09-14
10705034799964ChronOS710.021.99S71002199S2015-09-14
10705034799971ChronOS710.025.99S71002599S2015-09-14
10705034799988ChronOS710.026.99S71002699S2015-09-14
10705034799995ChronOS710.027.99S71002799S2015-09-14
10705034800004ChronOS710.038.99S71003899S2015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115935677XL AdaptorPREMIA SPINE LTDMNH2026-10-20
07290115935905XL Screwdriver CMPREMIA SPINE LTDMNH2026-10-20
07290115935912Screwdriver CMPREMIA SPINE LTDMNH2026-10-20
07290115935929Tube for K-wire over a k-wire technique 470mm (Nitinol)PREMIA SPINE LTDMNH2026-10-20
07290115935936Tube for XL K-Wire 450mmPREMIA SPINE LTDMNH2026-10-20
07290115935943Tube for K-Wires of 470mmPREMIA SPINE LTDMNH2026-10-20
07290115935950Tube for K-Wires up to 340mmPREMIA SPINE LTDMNH2026-10-20
07290115932874Cannulated Screwdriver inner shaftPREMIA SPINE LTDMNH2026-10-18
07290115932881Cannulated Screwdriver Handle AssyPREMIA SPINE LTDMNH2026-10-18
M697X07300251Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X073825100DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382560DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382565DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382570DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382575DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382580DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382585DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382590DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382595DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
08806364689439Kora Spinal SystemMedyssey Co., Ltd.MNH2026-10-01
08806364690077Kora Spinal SystemMedyssey Co., Ltd.MNH2026-10-01
00840916152413TALONSPINAL ELEMENTSMNH2020-04-14
00840916152420TALONSPINAL ELEMENTSMNH2020-04-14
00840916152437TALONSPINAL ELEMENTSMNH2020-04-14
00840916152444TALONSPINAL ELEMENTSMNH2020-04-14
00840916152529TALONSPINAL ELEMENTSMNH2020-04-14
00840916152536TALONSPINAL ELEMENTSMNH2020-04-14
10888857001428DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05