FDA.reportPublic FDA data

PRECICE Intramedullary Limb Lengthening System

Primary DI
00856719002893
Brand
PRECICE Intramedullary Limb Lengthening System
Company
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Model
LSB5-025
Catalog number
LSB5-025
Device description
5.0 mm Locking Screw 25 mm Length
Published
2015-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856719002893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856719002893008567190028938567190028930856719002893

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
837845234
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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