FDA.reportPublic FDA data

Sagittae

Primary DI
00819837021221
Brand
Sagittae
Company
SPINEEX, INC.
Model
013-030-11
Catalog number
013-030-11
Device description
Bone Graft Delivery System, 30 cc
Published
2020-05-14
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200816000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200816000SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.2020-04-30MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819837021221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819837021221008198370212218198370212210819837021221

GMDN Terms#

Term, Definition table
TermDefinition
Bone graft funnelA device designed to deliver bone graft filling material (autologous, allogeneic, xenogeneic, or synthetic) during an orthopaedic procedure to enable the filling of bone gaps intended to be fused. It is a funnel-shaped device; the funnel being bowl-shaped with the ability to hold back the filling material depending upon the angle of tilt applied by the surgeon, and a long, thin tube that can be inserted into the site to be filled, e.g., a cancellous bone graft being discharged into the posterior disc space of a vertebra. An orthopaedic graft inserter can be pushed down the funnel tube to press the graft material into the site. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume30Milliliter

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
04251631420200NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420217NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420224NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420231NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420248NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420255NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420262NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420279NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420286NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420293NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420309NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420316NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420323NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420330NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420347NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420354NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420361NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420378NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420385NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420392NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420408NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420415NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420422NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420439NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420446NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420453NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420460NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420477NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420484NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420491NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06