FDA.reportPublic FDA data

External Remote Controller

Primary DI
00887517014979
Brand
External Remote Controller
Company
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Model
ERC 4P
Catalog number
EAD-P4-010
Device description
PRECICE ERC 4P Shipping Pkg US
Published
2019-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
HSBRod, Fixation, Intramedullary And Accessories
HWCScrew, Fixation, Bone
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191336000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191336000PRECICE SystemNuvasive Specialized Orthopedics, Inc.2019-09-26HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517014979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517014979008875170149798875170149790887517014979

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
00195377108555PRECICETPT6-110-B-S2023-10-04
00195377108562PRECICETPT6-105-B-S2023-10-04
00195377108579PRECICETPT6-100-B-S2023-10-04
00195377108586PRECICETPT6-950-B-S2023-10-04
00195377108593PRECICETPT6-900-B-S2023-10-04
00195377108609PRECICETPT6-850-B-S2023-10-04
00195377108623PRECICETPT6-750-B-S2023-10-04
00195377108630PRECICETPT6-700-B-S2023-10-04
00195377108647PRECICETPT6-650-B-S2023-10-04
00195377108654PRECICETPT6-600-B-S2023-10-04
00195377108661PRECICETPT6-110-A-S2023-10-04
00195377108678PRECICETPT6-105-A-S2023-10-04
00195377108685PRECICETPT6-100-A-S2023-10-04
00195377108692PRECICETPT6-950-A-S2023-10-04
00195377108708PRECICETPT6-900-A-S2023-10-04
00195377108715PRECICETPT6-850-A-S2023-10-04
00195377108722PRECICETPT6-800-A-S2023-10-04
00195377108739PRECICETPT6-750-A-S2023-10-04
00195377108746PRECICETPT6-700-A-S2023-10-04
00195377108753PRECICETPT6-650-A-S2023-10-04

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