FDA.reportPublic FDA data

PRECICE® Intramedullary Limb Lengthening System

Primary DI
00812258026530
Brand
PRECICE® Intramedullary Limb Lengthening System
Company
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Model
ERC2P-LAPTOP US
Catalog number
ERC2P-LAPTOP US
Device description
ERC 2P Laptop Assembly US
Published
2020-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

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
K131490000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131490000ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEMEllipse Technologies, Inc.2014-01-23HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812258026530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812258026530008122580265308122580265300812258026530

GMDN Terms#

Term, Definition table
TermDefinition
Distraction plate/rod controllerA portable, hand-held, electrically-powered device intended to be used to non-invasively and remotely adjust the length of a previously-implanted orthopaedic distraction plate and/or rod (nail); it is not used during the implantation procedure. It is intended to be used with extramedullary distraction plates and/or intramedullary distraction rods to correct long bone fractures and limb length discrepancies, and/or with spinal distraction rods to correct spinal deformities.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-435-5477csdepartment@nuvasive.com
866-456-2871info@globusmedical.com

Regulatory Flags#

DUNS number
837845234
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887517952219PRECICE® STRYDE SystemSST-010-000SST-010-0002018-10-19
00887517952226PRECICE® STRYDE SystemSST-010-005SST-010-0052018-10-19
00887517952233PRECICE® STRYDE SystemSST-010-010SST-010-0102018-10-19
00887517952240PRECICE® STRYDE SystemSST-010-015SST-010-0152018-10-19
00887517952257PRECICE® STRYDE SystemSST-010-020SST-010-0202018-10-19
00887517952264PRECICE® STRYDE SystemSST-013-000SST-013-0002018-10-19
00887517952271PRECICE® STRYDE SystemSST-013-005SST-013-0052018-10-19
00887517952288PRECICE® STRYDE SystemSST-013-010SST-013-0102018-10-19
00887517952295PRECICE® STRYDE SystemSST-013-015SST-013-0152018-10-19
00887517952301PRECICE® STRYDE SystemSST-013-020SST-013-0202018-10-19
00887517001139PRECICE® Intramedullary Limb Lengthening SystemCPA2-000CPA2-0002017-10-10
00887517001146PRECICE® Intramedullary Limb Lengthening SystemCPA2-005CPA2-0052017-10-10
00887517001153PRECICE® Intramedullary Limb Lengthening SystemCPA2-010CPA2-0102017-10-10
00887517001160PRECICE® Intramedullary Limb Lengthening SystemCPA2-015CPA2-0152017-10-10
00887517001177PRECICE® Intramedullary Limb Lengthening SystemCPA2-020CPA2-0202017-10-10
00887517001184PRECICE® Intramedullary Limb Lengthening SystemCPA3-000CPA3-0002017-10-10
00887517001191PRECICE® Intramedullary Limb Lengthening SystemCPA3-005CPA3-0052017-10-10
00887517001207PRECICE® Intramedullary Limb Lengthening SystemCPA3-010CPA3-0102017-10-10
00887517001214PRECICE® Intramedullary Limb Lengthening SystemCPA3-015CPA3-0152017-10-10
00887517001221PRECICE® Intramedullary Limb Lengthening SystemCPA3-020CPA3-0202017-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10855068008003CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008010CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008027CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008034CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008041CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008058CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008065CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008072CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008089CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008096CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008102CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
07898624869669NEONAIL Neoortho Produtos Ortopédicos S/A.HSB2015-10-21
07898624869140NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869157NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869164NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869171NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869188NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869195NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869201NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869218NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869225NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869232NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869249NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869256NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06