FDA.reportPublic FDA data

BioBridge

Primary DI
10814493010609
Brand
BioBridge
Company
ACUTE INNOVATIONS LLC
Model
RRP1501
Device description
18 Hole Resorbable Rib Plate
Published
2015-09-03
Public version status
Update
Distribution status
Not 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
HRSPlate, Fixation, Bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814493010609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081449301060910814493010609

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, bioabsorbableA small, implantable sheet of firm material that is attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is chemically degraded and typically absorbed by natural body processes (e.g., a degradable polymer). The device is typically used for smaller post-traumatic or pathological orthopaedic fractures (e.g., of the hand or wrist). It may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit110 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18666234137customerservice@acuteinnovations.com

Regulatory Flags#

DUNS number
619225415
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10814493010012RibLocRBP11012015-09-03
10814493010029RibLocRBP11022015-09-03
10814493010036RibLocRBP11032015-09-03
10814493010043RibLocRBP11042015-09-03
10814493010050RibLocRBP11212015-09-03
10814493010067RibLocRBP11222015-09-03
10814493010074RibLocRBP11232015-09-03
10814493010081RibLocRBP11242015-09-03
10814493010098RibLocRBP11312015-09-03
10814493010104RibLocRBP11322015-09-03
10814493010111RibLocRBP11332015-09-03
10814493010128RibLocRBP11342015-09-03
10814493010135RibLocRBP12012015-09-03
10814493010142RibLocRBP12022015-09-03
10814493010159RibLocRBP12032015-09-03
10814493010166RibLocRBP12042015-09-03
10814493010173RibLocRBP12112015-09-03
10814493010180RibLocRBP12122015-09-03
10814493010197RibLocRBP12132015-09-03
10814493010203RibLocRBP12142015-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008405368000393P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000463P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000533P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000603P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
08809986479938CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
08809986479945CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
00370056966385Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658151Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658175Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658199Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569662202Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663247Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663841Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663865Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663872Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663889Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663896Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663902Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663919Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663926Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663933Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663940Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663964Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569671327Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676438Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676445Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676452Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676469Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
00850080543009PC Fix Locking Post TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543016PC Fix Locking Cap TiChest Wall Innovations, Inc.HRS2026-06-01