FDA.reportPublic FDA data

Pectus Blu (TM)

Primary DI
00888233086127
Brand
Pectus Blu (TM)
Company
BIOMET MICROFIXATION, INC
Model
78-0055
Catalog number
78-0055
Published
2026-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K261002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261002000Pectus Blu SystemBiomet Microfixation2026-06-02HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888233086127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888233086127008882330861278882330861270888233086127

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. It is typically in the form of pliers, a rod-like (e.g., pin) or bench-top device. This is a reusable device.

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
true
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
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
00888233086134Pectus Blu (TM)78-720078-72002026-07-23
00888233086141Pectus Blu (TM)78-725078-72502026-07-23
00888233086158Pectus Blu (TM)78-730078-73002026-07-23
00888233086165Pectus Blu (TM)78-735078-73502026-07-23
00888233086172Pectus Blu (TM)78-740078-74002026-07-23
00888233086189Pectus Blu (TM)78-745078-74502026-07-23
00888233086196Pectus Blu (TM)78-750078-75002026-07-23
00888233086202Pectus Blu (TM)78-755078-75502026-07-23
00888233086219Pectus Blu (TM)78-800178-80012026-07-23
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00810128536875PECTUS BLU (TM)78-850078-85002024-09-30
00888233077170PECTUS BLU (TM)78-800078-80002024-09-30
00888233077187PECTUS BLU (TM)78-808078-80802024-09-30
00888233077194PECTUS BLU (TM)78-808178-80812024-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889095401820ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401844ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401868ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401882ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401905ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401929ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402285ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402438ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402483ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402537ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411263ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411287ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411300ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411324ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095611274ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
10886982350732VOLTSynthes GmbHHRS2026-09-25
10886982350749VOLTSynthes GmbHHRS2026-09-25
10886982350756VOLTSynthes GmbHHRS2026-09-25
10886982350763VOLTSynthes GmbHHRS2026-09-25
10886982350770VOLTSynthes GmbHHRS2026-09-25
10886982350787VOLTSynthes GmbHHRS2026-09-25
10886982350794VOLTSynthes GmbHHRS2026-09-25
10886982350800VOLTSynthes GmbHHRS2026-09-25
10886982350817VOLTSynthes GmbHHRS2026-09-25
10886982350824VOLTSynthes GmbHHRS2026-09-25
10886982350831VOLTSynthes GmbHHRS2026-09-25
10886982350848VOLTSynthes GmbHHRS2026-09-25
10886982350855VOLTSynthes GmbHHRS2026-09-25
10886982350862VOLTSynthes GmbHHRS2026-09-25
10886982350879VOLTSynthes GmbHHRS2026-09-25