FDA.reportPublic FDA data

Sagittae

Primary DI
00819837020545
Brand
Sagittae
Company
SPINEEX, INC.
Model
502-030-16
Catalog number
502-030-16
Device description
Sagittae Independent Driver, LONG, 465 SST
Published
2019-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819837020545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819837020545008198370205458198370205450819837020545

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant driverA hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5105736165info@spineexinc.com

Regulatory Flags#

DUNS number
080723590
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819837020019Sagittae010-030-42010-030-422019-02-06
00819837020026Sagittae010-030-46010-030-462019-02-06
00819837020033Sagittae010-030-50010-030-502019-02-06
00819837020040Sagittae010-030-54010-030-542019-02-06
00819837020057Sagittae010-030-58010-030-582019-02-06
00819837020309Sagittae012-030-10012-030-102020-05-14
00819837020361Sagittae012-030-20012-030-202020-05-14
00819837021108Sagittae012-030-11012-030-112020-05-14
00819837021122Sagittae012-030-21012-030-212020-05-14
00819837020071Sagittae012-030-00012-030-002019-02-06
00819837020132Sagittae521-030-00521-030-002019-02-06
00819837021207Sagittae014-030-22014-030-222020-05-14
00819837021245Sagittae075-030-10075-030-102020-05-14
00819837020064Sagittae075-030-00075-030-002019-02-06
00819837021146Sagittae076-030-00076-030-002019-10-21
00819837021283Sagittae902-030-05902-030-052021-09-22
00819837021320Sagittae902-030-15902-030-152021-09-22
00819837020804Sagittae025-030-09025-030-092020-05-14
00819837020828Sagittae025-030-10025-030-102020-05-14
00819837020842Sagittae025-030-11025-030-112020-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197157076047ZAVATION DISTRACTORZavation LLCMAX2026-05-28
00197157076054ZAVATION DISTRACTORZavation LLCMAX2026-05-28
00197157076061ZAVATION DISTRACTORZavation LLCMAX2026-05-28
00197157075859ZAVATION INSERTERZavation LLCMAX2026-05-27
00810166522366X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
00810166522373X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
B70712535005S0Dual X Graft Tamp ShortAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010130DUALXS T/PLIF 15 DEG x 9-12MMAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010200DUALXS T/PLIF 18 DEG x 10-13MMAMPLIFY SURGICAL, INC.MAX2026-05-27
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07613153046394AVS TLStryker CorporationMAX2015-09-14
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