FDA.reportPublic FDA data

PRECICE® Plating System

Primary DI
00887517021281
Brand
PRECICE® Plating System
Company
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Model
LP4.5-PRT4B
Catalog number
LP4.5-PRT4B
Device description
PRECICE Plate 4.5mm Proximal Tibia Plate, Right, 45mm, Bump
Published
2020-01-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192181000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192181000PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.2019-11-07KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517021281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517021281008875170212818875170212810887517021281

GMDN Terms#

Term, Definition table
TermDefinition
Long bone distraction plate, magneticAn implantable device in the form of a plate, capable of adjusting in length, designed to be attached to a long bone to hold the ends of a fractured bone in position to promote healing, or to support the bone in the presence of a pathological condition, or for limb lengthening procedures; each plate is specific to a particular long bone (e.g., femur, humerus, tibia). It consists of overlapping plates, connected to the bone by locking screws, which have one or more integrated magnets that move in response to a noninvasive magnetic control device to adjust length.

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
Expiration 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

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