FDA.reportPublic FDA data

PediLoc Tibial Plate

Primary DI
00841132111123
Brand
PediLoc Tibial Plate
Company
ORTHOPEDIATRICS CORP.
Model
00-0903-2666
Catalog number
00-0903-2666
Device description
3.5mm Locking Cortical Screw with T15 Hexalobe, Size 66mm
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100240000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100240000ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEMOrthoPediatrics Corp.2010-05-17HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841132111123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132111123008411321111238411321111230841132111123

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(574)268-6379Rbremer@orthopediatrics.com

Regulatory Flags#

DUNS number
796416191
Device count
1
DM exempt
true
Lot or batch
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
00885556904879EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556904923EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906163EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906170EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906187EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906194EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906200EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906217EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906224EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906231EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906248EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906255EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906262EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906279EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906286EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906293EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906309EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906316EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906323EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556901946EVOSSmith & Nephew, Inc.HWC2026-06-24
00193982586393CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586416CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586430CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586454CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586478CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586690CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586706CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586713CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586720CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586737CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10