FDA.reportPublic FDA data

LCB

Primary DI
00841132137093
Brand
LCB
Company
ORTHOPEDIATRICS CORP.
Model
00-1200-8048
Catalog number
00-1200-8048
Device description
110° CANN ADOL BLADE PLATE 60MM X 10MM OFFSET X 4 HOLE
Published
2017-03-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

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
K110959000
K260323000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110959000ORTHOPEDIATRICS BLADE PLATE SYSTEMOrthoPediatrics Corp.2011-08-05HRS
K260323000OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.2026-04-30HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841132137093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132137093008411321370938411321370930841132137093

GMDN Terms#

Term, Definition table
TermDefinition
Growth-correction orthopaedic fixation plate kitA collection of implantable devices used to redirect the angle of growth of long bones in paediatric patients where the growth plates (epiphysial cartilage) are not fused, to allow for the gradual correction of congenital or acquired deformities (e.g., valgus, varus, or flexion deformities of the knee, ankle, or elbow). It typically includes various-sized sheets of surgical steel or titanium alloy, and bone screws to attach the sheets to the bone surface over the growth plates. The screws may be allowed to swivel in their position so that the implant acts like a hinge, permitting growth at the growth plate to gradually straighten the limb.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(574)268-6379Rbremer@orthopediatrics.com
+1(574)268-6379xxx@xxx.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
00841132133200PediFlex01-1000-00101-1000-0012017-02-15
00841132133217PediFlex01-1000-00201-1000-0022017-02-15
00841132135280PediNail21-1500-00721-1500-0072017-02-15
00841132135297PediNail21-1500-01021-1500-0102017-02-15
00841132135303PediNail21-1500-01221-1500-0122017-02-15
00841132135310PediNail21-1500-01321-1500-0132017-02-15
00841132135334PediNail21-1500-01921-1500-0192017-02-15
00841132135341PediNail21-1500-11221-1500-1122017-02-15
00841132135358PediNail21-1500-11921-1500-1192017-02-15
00841132135372PediNail21-1500-911321-1500-91132017-02-15
00841132135389PediNail21-1500-921321-1500-92132017-02-15
00841132135396PediNail21-1500-921421-1500-92142017-02-15
00841132179833Vilex ToolP460-45-100P460-45-1002020-03-02
00841132179888Orthex ToolPP460-15-110PP460-15-1102020-03-02
00841132142325eZ-Fix500-G500-G2020-02-28
00841132142905eZ-Fix900-CW-14900-CW-142020-02-28
00841132142950eZ-Fix900-TW-30900-TW-302020-02-28
00841132143025eZ-Fix925-TW-30925-TW-302020-02-28
00841132125014General Instrument01-1003-300101-1003-30012016-09-25
00841132125021General Instrument01-1003-300201-1003-30022016-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904255300064ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300071ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300088ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300095ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300101ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300118ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300125ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300132ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300149ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300156ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300163ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300170ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300187ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300194ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300200ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300217ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300224ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300231ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300248ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300255ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300262ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300705ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300712ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300729ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300736ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300743ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300750ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300767ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300774ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300781ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18