FDA.reportPublic FDA data

Osseoflex®

Primary DI
00884450327937
Brand
Osseoflex®
Company
Merit Medical Systems, Inc.
Model
00884450327937
Catalog number
OT-0224/A
Published
2018-04-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K150607000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150607000Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2mlOsseon, LLC2015-04-09NDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450327937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450327937008844503279378844503279370884450327937

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450099346Merit Medical®Initial ReleaseK05-02879B2026-11-05
00884450163351Merit Medical®Initial ReleaseK09-11704C2026-11-05
00884450420034Merit Medical®Initial ReleaseK09-14260A2026-11-05
00884450420263Merit Medical®Initial ReleaseK09-11289A2026-11-05
00884450431535Merit Medical®Initial ReleaseK12-04729B2026-11-05
00884450436530Merit Medical®Initial ReleaseK09-05978D2026-11-05
00884450436974Merit Medical®Initial ReleaseK09-09344D2026-11-05
00884450508763Merit Medical®Initial ReleaseK09-13864D2026-11-05
00884450163917Merit Medical®Initial ReleaseK09-12030B2026-11-04
00884450431443Merit Medical®Initial ReleaseK08-03296A2026-11-04
00884450456385ReSolve®GRBDC-14-0382026-11-04
00884450503829Merit Medical®Initial ReleaseK09-13310D2026-11-04
00884450794739DuraMax®AH7871030290152026-11-03
00884450838228Prelude Roadster™APG8F45S2026-11-03
00884450839355Prelude Roadster™APG7F90SX2026-11-04
10884450708467Prelude®FPSI-7F-11-038-18G2026-11-03
00884450148174Merit Medical®Initial ReleaseK09-09012A2026-10-31
00884450428061Merit Medical®Initial ReleaseK10-01518B2026-10-31
00884450436936Merit Medical®Initial ReleaseK12-07972A2026-10-30
00884450499191Merit MAK™GMAK401N-E2026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000750282CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-11-01
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
08058964728692Winch Kyphoplasty Balloon Catheter 15G 10 mmG21 SRLNDN2026-09-30
08058964728708Winch Kyphoplasty Balloon Catheter 15G 15 mmG21 SRLNDN2026-09-30
08809695579813Trocar Needle (Working Channel)GS Medical Co., Ltd.NDN2026-07-27
08809695579820Bevel Needle (Working Channel)GS Medical Co., Ltd.NDN2026-07-27
00884450843215StabiliT®Merit Medical Systems, Inc.NDN2026-04-15
00884450843222StabiliT®Merit Medical Systems, Inc.NDN2026-03-31
03701505801204DynamoTEKNIMEDNDN2026-02-02
04260102139411OSTEOPAL®Heraeus Medical GmbHNDN2025-09-26
00815212026966OS 11G BONE FILLER KIT-OSTEOFIXIzi Medical Products, LLCNDN2025-03-26
00889095358230CONCORDGLOBUS MEDICAL, INC.NDN2024-12-01
00889095358247CONCORDGLOBUS MEDICAL, INC.NDN2024-12-01
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONNDN2024-11-21
07613327638226OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638233OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638240OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638257OmnicurveSTRYKER CORPORATIONNDN2024-09-03