FDA.reportPublic FDA data

DynaBridge

Primary DI
00840124507104
Brand
DynaBridge
Company
FUSION ORTHOPEDICS, LLC
Model
CD-OP-1003-C
Catalog number
CD-OP-1003-C
Device description
YOCO Blade Akin Conmed
Published
2022-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HSOSaw
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSOSawGeneral, Plastic Surgery1
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181815000
K202959000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181815000DynaBridgeFusion Orthopedics, LLC2018-10-15JDR
K202959000PolyLock Plating SystemFusion Orthopedics, LLC2020-11-24HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840124507104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124507104008401245071048401245071040840124507104

GMDN Terms#

Term, Definition table
TermDefinition
Surgical saw blade, oscillating, single-useA flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge and designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at its distal end to cut in a rapid oscillating (circular/arc-shaped) motion; it is not intended to perform a sagittal motion. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080307067
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840124525603FibFixCD-FN-4037-SCD-FN-4037-S2026-05-11
00840124525610FibFixCD-FN-4047-SCD-FN-4047-S2026-05-11
00840124525627FibFixCD-FN-4057-SCD-FN-4057-S2026-05-11
00840124525634FibFixCD-FN-4037CD-FN-40372026-05-11
00840124525641FibFixCD-FN-4047CD-FN-40472026-05-11
00840124525658FibFixCD-FN-4057CD-FN-40572026-05-11
00840124521407Metalogix9003179003172025-09-30
00840124521414Metalogix9003209003202025-09-30
00840124525542FibFixTN-FN-9908TN-FN-99082026-04-23
00840124525559FibFixTN-FN-9912TN-FN-99122026-04-23
00840124525566FuzeFix LargeTN-FT-7096TN-FT-70962026-04-23
00840124525573FuzeFix LargeTN-FT-7070TN-FT-70702026-04-23
00840124525580FuzeFix LargeTN-FT-7024TN-FT-70242026-04-23
00840124525597FuzeFix LargeTN-FT-7050TN-FT-70502026-04-23
00819034022557TalarLift STS CD-TL-5050CD-TL-50502019-04-29
00840124525535Metalogix RevolutionTN-TR-0092TN-TR-00922026-04-17
00840124516113FibFixFN-SS-4014FN-SS-40142026-04-09
00840124516120FibFixFN-SS-40162026-04-09
00840124516137FibFixFN-SS-4018FN-SS-40182026-04-09
00840124516144FibFixFN-SS-4020FN-SS-40202026-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810189450783Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450790Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450806Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450813Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450820Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450837Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450844Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450851Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450868Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450875Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450882Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450899Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450905Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450912Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450929Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450936Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450943Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450950Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450967Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450974Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450981Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189451087Surgical DesignSurgical Design, Inc.HSO2026-06-06
03700569658212Xpert PFPNEWCLIP TECHNICSHWC2026-06-03
00842188131981CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02