FDA.reportPublic FDA data

SYMPHONY

Primary DI
10705034528960
Brand
SYMPHONY
Company
Medos International Sàrl
Model
1020-40-110S
Catalog number
102040110S
Device description
SYMPHONY OCT SYSTEM POLYAXIAL SCREW diameter 4.0 Rod, 4.0X10mm 3.5 and 4.0
Published
2020-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
NKGPosterior cervical screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181949000
K190895000
K192014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181949000SYMPHONY™ OCT SystemMedos International SARL2018-10-04NKG
K190895000MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation SystemMedos International SARL2019-07-18NKG
K192014000SYPMHONY™ OCT SystemMedos International SARL2020-01-24NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034528960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503452896010705034528960

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of 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. Sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
482661753
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705032266NA2423332423332026-07-22
10886705001309RIGIDFIX BIOCRYL2108162108162015-09-01
10705034647302CROSSNAV CONDUIT3010-21-9963010219962026-07-09
10705034647319CROSSNAV CONDUIT3010-21-9993010219992026-07-09
10705034647326CROSSNAV CONDUIT3010-21-3323010213322026-07-09
10705034647333CROSSNAV CONDUIT3010-21-3313010213312026-07-09
10705034647340CROSSNAV CONDUIT3010-21-2103010212102026-07-09
10705034647357CROSSNAV CONDUIT3010-21-2113010212112026-07-09
10705034647364CROSSNAV CONDUIT3010-21-2123010212122026-07-09
10705034647371CROSSNAV CONDUIT3010-21-2133010212132026-07-09
10705034647388CROSSNAV CONDUIT3010-21-2143010212142026-07-09
10705034647395CROSSNAV CONDUIT3010-21-2153010212152026-07-09
10705034647418CROSSNAV CONDUIT3010-21-2083010212082026-07-09
10705034647425CROSSNAV CONDUIT3010-21-2093010212092026-07-09
10705034647432CROSSNAV CONDUIT3010-21-3203010213202026-07-09
10705034647449CROSSNAV CONDUIT3010-21-3153010213152026-07-09
10705034647456CROSSNAV CONDUIT3010-21-9983010219982026-07-09
10705034647463N/A3010-21-3403010213402026-07-09
10705034647470CROSSNAV CONDUIT3010-21-3013010213012026-07-09
10705034647487CROSSNAV CONDUIT3010-21-3033010213032026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-08-02
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-30
00840606193382Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193399Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193405Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193412Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193429Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193436Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193443Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193450Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194044Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194051Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194068Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194075Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194082Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194099Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194105Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194112Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194129Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194136Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194143Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194150Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194167Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194174Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194181Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194198Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194204Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194211Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194228Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194235Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30