FDA.reportPublic FDA data

PediLoc Fragment System

Primary DI
00840194466738
Brand
PediLoc Fragment System
Company
ORTHOPEDIATRICS CORP.
Model
00-1005-2402
Catalog number
00-1005-2402
Device description
2.7mm Locking T-Plate, 3 Hole Head, 2 Hole
Published
2024-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K140431000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140431000PEDILOC FRAGMENT SYSTEMOrthoPediatrics Corp.2014-07-29HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840194466738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194466738008401944667388401944667380840194466738

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

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
00840194405980Pediatric Nailing Platform Femur01-1501-052001-1501-05202022-09-16
00840194405997Pediatric Nailing Platform Femur01-1503-005501-1503-00552022-09-16
00840194406000Pediatric Nailing Platform Femur01-1503-005601-1503-00562022-09-16
00840194407687Pediatric Nailing Platform Femur01-1501-010201-1501-01022022-09-16
00840194407700Pediatric Nailing Platform Femur01-1503-005701-1503-00572022-09-16
00840194407717Pediatric Nailing Platform Femur01-1503-005801-1503-00582022-09-16
00840194407724Pediatric Nailing Platform Femur01-1503-005901-1503-00592022-09-16
00840194407748Pediatric Nailing Platform Femur01-1501-052101-1501-05212022-09-16
00840194417280Pediatric Nailing Platform Femur01-1501-015001-1501-01502022-09-16
00840194417297Pediatric Nailing Platform Femur01-1501-015101-1501-01512022-09-16
00840194417303Pediatric Nailing Platform Femur01-1501-015201-1501-01522022-09-16
00840194417310Pediatric Nailing Platform Femur01-1501-052201-1501-05222022-09-16
00840194417327Pediatric Nailing Platform Femur01-1501-052301-1501-05232022-09-16
00840194417334Pediatric Nailing Platform Femur01-1501-052401-1501-05242022-09-16
00840194445986Pediatric Nailing Platform | Tibia01-1510-005001-1510-00502023-09-15
00840194445993Pediatric Nailing Platform | Tibia01-1510-005101-1510-00512023-09-15
00840194462587Pediatric Nailing Platform | Tibia01-1540-000001-1540-00002023-09-15
00840194462594Pediatric Nailing Platform | Tibia01-1540-000101-1540-00012023-09-15
00840194462686Pediatric Nailing Platform | Tibia01-1510-006001-1510-00602023-09-15
00840194462693Pediatric Nailing Platform | Tibia01-1510-006101-1510-00612023-09-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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