FDA.reportPublic FDA data

PECTUS BLU (TM)

Primary DI
00888233077224
Brand
PECTUS BLU (TM)
Company
BIOMET MICROFIXATION, INC
Model
78-8300
Catalog number
78-8300
Published
2024-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241709000
K261002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241709000Pectus Blu Support Bar SystemBiomet Microfixation2024-09-19HRS
K261002000Pectus Blu SystemBiomet Microfixation2026-06-02HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888233077224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888233077224008882330772248882330772240888233077224

GMDN Terms#

Term, Definition table
TermDefinition
Funnel chest remodelling barA non-sterile implantable device intended to be used to reduce the deformity of pectus excavatum (funnel chest) by applying outward force from a position deep to the sternum to reposition the sternum; it is typically used in paediatric patients and surgically removed when remodelling is evident (after 2-3 years). It is a thin curved bar, with or without serrations, made of metal [e.g., stainless steel, titanium (Ti)] that can be anchored with wires or with stabilizer plates laterally on the rib cage. This is a single-patient device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
046189866
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00888233025140N/A02-290202-29022020-06-26
00888233025157N/A02-290502-29052020-06-26
00888233025164N/A02-310102-31012020-06-26
00888233025171N/A02-310202-31022020-06-26
00888233025188N/A02-310502-31052020-06-26
00888233025195N/A02-311002-31102020-06-26
00888233025201N/A7014-32667014-32662020-06-26
00841036125844ALLOGENIX02-31012015-09-24
00841036125851ALLOGENIX02-31022015-09-24
00841036125868ALLOGENIX02-31052015-09-24
00841036125875ALLOGENIX02-31102015-09-24
00841036181468ALLOGENIX PLUS02-29022015-09-24
00841036181475ALLOGENIX PLUS02-29052015-09-24
00841036019112N/A02-008302-00832017-06-05
00888233028875Pectus Blu (TM)78-880178-88012026-07-23
00888233028882Pectus Blu (TM)78-880278-88022026-07-23
00888233028899Pectus Blu (TM)78-880378-88032026-07-23
00888233086110Pectus Blu (TM)78-005378-00532026-07-23
00888233086127Pectus Blu (TM)78-005578-00552026-07-23
00888233086134Pectus Blu (TM)78-720078-72002026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810112592245TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592252TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592429TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592450TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592474TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592634TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592832TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592849TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592986TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112592993TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593006TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593013TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593020TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593037TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593044TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593051TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593068TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593075TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593082TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593099TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593105TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593112TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593129TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593136TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593143TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593150TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593167TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593174TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593181TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593198TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22