FDA.reportPublic FDA data

Pediatric Nailing Platform Tibia

Primary DI
00840194445863
Brand
Pediatric Nailing Platform Tibia
Company
ORTHOPEDIATRICS CORP.
Model
00-1530-1010
Catalog number
00-1530-1010
Device description
PNP Tibia Cannulated End Cap 10.5mm x 10mm
Published
2023-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231266000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231266000Pediatric Nailing Platform TibiaOrthoPediatrics Corp.2023-08-21HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840194445863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194445863008401944458638401944458630840194445863

GMDN Terms#

Term, Definition table
TermDefinition
Tibia nailA rod made of metal or other material intended to be implanted into the intramedullary canal of the tibia to immobilize the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
796416191
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841132125014General Instrument01-1003-300101-1003-30012016-09-25
00841132125021General Instrument01-1003-300201-1003-30022016-09-25
00841132125038General Instrument01-1003-300301-1003-30032016-09-25
00841132124277ACL01-1008-253001-1008-25302021-07-06
00841132122112OrthoPediatrics ACL Reconstruction System10-1008-106010-1008-10602015-09-18
00841132122129OrthoPediatrics ACL Reconstruction System10-1008-106510-1008-10652015-09-18
00841132122136OrthoPediatrics ACL Reconstruction System10-1008-107010-1008-10702015-09-18
00841132122143OrthoPediatrics ACL Reconstruction System10-1008-107510-1008-10752015-09-18
00841132122150OrthoPediatrics ACL Reconstruction System10-1008-108010-1008-10802015-09-18
00841132122167OrthoPediatrics ACL Reconstruction System10-1008-108510-1008-10852015-09-18
00841132122174OrthoPediatrics ACL Reconstruction System10-1008-109010-1008-10902015-09-18
00841132122181OrthoPediatrics ACL Reconstruction System10-1008-110010-1008-11002015-09-18
00841132122198OrthoPediatrics ACL Reconstruction System10-1008-406010-1008-40602015-09-18
00841132122204OrthoPediatrics ACL Reconstruction System10-1008-406510-1008-40652015-09-18
00841132122211OrthoPediatrics ACL Reconstruction System10-1008-407010-1008-40702015-09-18
00841132122228OrthoPediatrics ACL Reconstruction System10-1008-407510-1008-40752015-09-18
00841132122235OrthoPediatrics ACL Reconstruction System10-1008-408010-1008-40802015-09-18
00841132122242OrthoPediatrics ACL Reconstruction System10-1008-408510-1008-40852015-09-18
00841132126219General Instrument01-1008-000701-1008-00072016-09-25
00841132126226General Instrument01-1008-001001-1008-00102016-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00193982660147AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660161AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660185AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660208AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660222AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660246AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660260AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660284AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660307AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660321AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
B058AHN08165L1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
B058AHN08165R1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
10855068008423Lock ActivatorCURVAFIX, INC.HSB2022-06-20
10855068008492Inserter/ExtractorCURVAFIX, INC.HSB2022-06-20
10855068008539Sterilization Case, OuterCURVAFIX, INC.HSB2022-06-20
10855068008621Ring Lock, Long InserterCURVAFIX, INC.HSB2022-06-20
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