FDA.reportPublic FDA data

Precice®

Primary DI
00887517028464
Brand
Precice®
Company
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Model
SFT4.5-275-S
Device description
4.5mm x 27.5mm Screw, Fully Threaded
Published
2021-06-15
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
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200430000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200430000Precice® Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc.2020-09-16HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517028464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517028464008875170284648875170284640887517028464

GMDN Terms#

Term, Definition table
TermDefinition
Arthrodesis distraction rodA rod, capable of adjusting in length, designed to be inserted into the bones on both sides of a joint to fuse the joint (e.g. tibia and calcaneus for ankle arthrodesis) and to facilitate subsequent limb lengthening, in traumatic repair or reconstructive procedures. It consists of telescoping rods connected to the bone with dedicated locking screws, which have one or more integrated magnets that move in response to a noninvasive magnetic control device (not included) to adjust length. It is made of metal or other material (e.g., carbon fibre). This is a single-use device.

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630894821714APTUSMedartis AGHWC2026-10-27
07630894821721APTUSMedartis AGHWC2026-10-27
07630894821738APTUSMedartis AGHWC2026-10-27
07630894821745APTUSMedartis AGHWC2026-10-27
07630894821752APTUSMedartis AGHWC2026-10-27
07630894821769APTUSMedartis AGHWC2026-10-27
07630894821776APTUSMedartis AGHWC2026-10-27
07630894821783APTUSMedartis AGHWC2026-10-27
07630894821790APTUSMedartis AGHWC2026-10-27
07630894821806APTUSMedartis AGHWC2026-10-27
07630894821813APTUSMedartis AGHWC2026-10-27
07630894821820APTUSMedartis AGHWC2026-10-27
07630894821837APTUSMedartis AGHWC2026-10-27
07630894821851APTUSMedartis AGHWC2026-10-27
07630894821875APTUSMedartis AGHWC2026-10-27
07630894821899APTUSMedartis AGHWC2026-10-27
07630894821912APTUSMedartis AGHWC2026-10-27
07630894821936APTUSMedartis AGHWC2026-10-27
07630894821950APTUSMedartis AGHWC2026-10-27
07630894821974APTUSMedartis AGHWC2026-10-27
07630894821998APTUSMedartis AGHWC2026-10-27
07630894822018APTUSMedartis AGHWC2026-10-27
07630894822032APTUSMedartis AGHWC2026-10-27
07630894822056APTUSMedartis AGHWC2026-10-27
07630894822070APTUSMedartis AGHWC2026-10-27
07630894822094APTUSMedartis AGHWC2026-10-27
07630894822117APTUSMedartis AGHWC2026-10-27
07630894822131APTUSMedartis AGHWC2026-10-27
07630894822155APTUSMedartis AGHWC2026-10-27
07630894822179APTUSMedartis AGHWC2026-10-27