FDA.reportPublic FDA data

Conventus Cage - PR, Small

Primary DI
00814289020754
Brand
Conventus Cage - PR, Small
Company
CONVENTUS ORTHOPAEDICS, INC.
Model
PR-S
Published
2015-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151379000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151379000Conventus PRS SystemConventus Orthopaedics, Inc.2015-08-13HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814289020754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814289020754008142890207548142890207540814289020754

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterileA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021231299
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814289020006Conventus Cage - DR, SmallDRS-S2015-09-18
00814289020013Conventus Cage - DR, LargeDRS-L2015-09-18
008142890200202.7mm x 8mm Cannulated Headed ScrewBH27082015-09-18
008142890200372.7mm x 10mm Cannulated Headed ScrewBH27102015-09-18
008142890200442.7mm x 12mm Cannulated Headed ScrewBH27122015-09-18
008142890200512.7mm x 14mm Cannulated Headed ScrewBH27142015-09-18
008142890200682.7mm x 16mm Cannulated Headed ScrewBH27162015-09-18
008142890200752.7mm x 18mm Cannulated Headed ScrewBH27182015-09-18
008142890200822.7mm x 20mm Cannulated Headed ScrewBH27202015-09-18
008142890200992.7mm x 22mm Cannulated Headed ScrewBH27222015-09-18
008142890201052.7mm x 24mm Cannulated Headed ScrewBH27242015-09-18
008142890201122.7mm x 26mm Cannulated Headed ScrewBH27262015-09-18
008142890201292.7mm x 28mm Cannulated Headed ScrewBH27282015-09-18
008142890201362.7mm x 30mm Cannulated Headed ScrewBH27302015-09-18
008142890201432.7mm x 32mm Cannulated Headed ScrewBH27322015-09-18
008142890201502.7mm x 34mm Cannulated Headed ScrewBH27342015-09-18
008142890201672.7mm x 36mm Cannulated Headed ScrewBH27362015-09-18
008142890201742.7mm x 38mm Cannulated Headed ScrewBH27382015-09-18
008142890201812.7mm x 40mm Cannulated Headed ScrewBH27402015-09-18
008142890201982.7mm x 42mm Cannulated Headed ScrewBH27422015-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888233028875Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233028882Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233028899Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086110Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086127Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086134Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086141Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086158Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086165Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086172Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086189Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086196Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086202Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086219Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
18059015376838Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376845Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376852Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376869Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376876Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376883Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376890Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376906Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376913Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376920Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376937Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376944Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376951Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376968Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376975Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376982Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23