FDA.reportPublic FDA data

MBA™

Primary DI
M248MBASET1
Brand
MBA™
Company
Ascension Orthopedics, Inc.
Model
MBASET
Device description
MBA™ Instrument Set (05-5000)
Published
2016-07-25
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051611000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051611000MBARESORB IMPLANTKinetikos Medical, Inc.2005-09-06HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780257288PrimaryGS10
M248MBASET1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178025728810381780257288

GMDN Terms#

Term, Definition table
TermDefinition
Subtalar implant, non-bioabsorbable, sterileA sterile device designed to be implanted into the calcaneus bone or sinus tarsi of the foot to stabilize the subtalar/talotarsal joint to treat a hyperpronated foot (inward rotation during gait) and sequelae (e.g., flat foot) or other heel/arch abnormalities. It is a non-bioabsorbable device typically made of a metal (e.g., titanium alloy) or polyethylene (PE).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
942377524
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
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
10381780240204Cadence™102030222016-08-24
10381780240211Cadence™10203023102030232016-08-24
10381780240228Cadence™10203024102030242016-08-24
10381780240235Cadence™102030252016-08-24
10381780240242Cadence™102030262016-08-24
10381780240754Cadence™10204202102042022016-08-24
10381780245612Titan™IMC096004301IMC-0960-043-012017-08-30
10381780246374Integra®OSG20000OSG-200-002017-08-30
10381780246381Integra®OSG20010POSG-200-10P2017-08-30
10381780246398Integra®OSG20010PVOSG-200-10PV2017-08-30
10381780246404Integra®OSG20020POSG-200-20P2017-08-30
10381780246411Integra®OSG20020PVOSG-200-20PV2017-08-30
10381780246428Integra®OSG20030POSG-200-30P2017-08-30
10381780246435Integra®OSG20030PVOSG-200-30PV2017-09-05
10381780246442Integra®OSG20040POSG-200-40P2017-09-05
10381780246459Integra®OSG20040PVOSG-200-40PV2017-08-30
10381780246466Integra®OSG35001OSG-350-012017-08-30
10381780246473Integra®OSG44200OSG-442-002017-09-05
10381780246480First Choice® DRUJ SystemOSG60000OSG-600-002017-09-05
10381780246497First Choice® DRUJ SystemOSG60001OSG-600-012017-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569633943NANEWCLIP TECHNICSHWC2026-10-01
03700569633967NANEWCLIP TECHNICSHWC2026-10-01
03700569633981NANEWCLIP TECHNICSHWC2026-10-01
03700569634001NANEWCLIP TECHNICSHWC2026-10-01
03700569634025NANEWCLIP TECHNICSHWC2026-10-01
03700569634049NANEWCLIP TECHNICSHWC2026-10-01
03700569634063NANEWCLIP TECHNICSHWC2026-10-01
08057717550535BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550542BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550566BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550580BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550597BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550610BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550627BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550641BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550665BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550689BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550702BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550726BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550740BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550764BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550788BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
00885556838211Total Foot System 2Smith & Nephew, Inc.HWC2023-04-18
00815432024322DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024339DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024353DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024377DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024391DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024407DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024421DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09