FDA.reportPublic FDA data

PRECICE® Bone Transport System

Primary DI
00887517981080
Brand
PRECICE® Bone Transport System
Company
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Model
BT10-10SA400-7
Catalog number
BT10-10SA400-7
Device description
Retrograde Femur 5° Bend – Three Holes, 10.0mm x 400mm, 7/10cm ST
Published
2019-04-12
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
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182170000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182170000PRECICE® BONE TRANSPORT™ SystemNuvasive Specialized Orthopedics, Inc.2019-02-05HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517981080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517981080008875179810808875179810800887517981080

GMDN Terms#

Term, Definition table
TermDefinition
Femur nail, sterileA sterile rod made of metal or other material which, when inserted into the intramedullary canal of the femur, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter10Millimeter

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
00888867417229Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417236Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417250Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417274Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417281Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417298Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417304Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417311Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417328Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417335Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417342Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417359Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417366Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417373Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417380Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417397Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417403Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417410Arthrex®ARTHREX, INC.HSB2026-07-22
00193982660086AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660109AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660123AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660147AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660161AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660185AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660208AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660222AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660246AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660260AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660284AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660307AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10