FDA.reportPublic FDA data

CONFIDENCE SPINAL CEMENT SYSTEM

Primary DI
10705034209623
Brand
CONFIDENCE SPINAL CEMENT SYSTEM
Company
Medos International Sàrl
Model
283910000
Catalog number
283910000
Device description
CONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE PLUS KIT SPINAL CEMENT SYSTEM 11cc
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDNCEMENT, BONE, VERTEBROPLASTY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDNCement, Bone, VertebroplastyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060300000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060300000CONFIDENCE HIGH VISCOSITY BONE CEMENTDisc-O-Tech Medical Technologies, Ltd.2006-06-21NDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034209623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503420962310705034209623

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius25 Degrees Celsius
Special Storage Condition, Specify00Flammable
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034442280EXPEDIUM VERSE™ SPINE SYSTEM1997216401997216402015-09-24
10705034442587EXPEDIUM VERSE™ SPINE SYSTEM1997214601997214602015-09-24
10705034369761SKYLINE4102701124102701122016-12-31
10705034369778SKYLINE4102701164102701162016-12-31
10705034369785SKYLINE4102701204102701202016-12-31
10705034369822SKYLINE4102702284102702282016-12-31
10705034369839SKYLINE4102702324102702322016-12-31
10705034369846SKYLINE4102702364102702362016-12-31
10705034369884SKYLINE4102703424102703422016-12-31
10705034369891SKYLINE4102703484102703482016-12-31
10705034369907SKYLINE4102703544102703542016-12-31
10705034369983SKYLINE4102901304102901302016-12-31
10705034648194VELYS4516110654516110652026-10-09
10705034648200VELYS4516110644516110642026-10-09
00856879006519FIBERGRAFT Aeridyan59000170590001702026-09-29
00856879006908FIBERGRAFT Aeridyan Matrix73000030730000302023-04-05
00856879006915FIBERGRAFT Aeridyan Matrix73000063730000632023-04-05
00856879006922FIBERGRAFT Aeridyan Matrix73000125730001252023-04-05
00856879006946FIBERGRAFT Aeridyan Matrix73000200730002002023-04-05
00856879006250FIBERGRAFT Aeridyan Matrix59000125590001252021-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000750411CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-11-01
00763000750503CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-11-01
00763000750497MSB CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-31
00763000749903CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-23
00763000750510CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-23
08058964729767Easy Winch 13 G, 15 mmG21 SRLNDN2026-10-19
08058964729774Easy Winch 13 G, 10 mmG21 SRLNDN2026-10-19
00763000750053CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00763000750251CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00763000750268CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00763000750275CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00763000750374CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00763000750404CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
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