FDA.reportPublic FDA data

RibLoc

Primary DI
10814493010173
Brand
RibLoc
Company
ACUTE INNOVATIONS LLC
Model
RBP1211
Device description
8mm x 2.3mm Intermediate Rib Screw
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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814493010173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081449301017310814493010173

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
18666234137customerservice@acuteinnovations.com

Regulatory Flags#

DUNS number
619225415
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
10814493010180RibLocRBP12122015-09-03
10814493010197RibLocRBP12132015-09-03
10814493010203RibLocRBP12142015-09-03
10814493010371RibLocRBL13012015-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810112592474TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
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00810112593037TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
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00810112593051TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593068TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593075TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593082TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593099TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593105TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
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00810112593129TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593136TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593143TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593150TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593167TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593174TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593181TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593198TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22