FDA.reportPublic FDA data

Sagittae

Primary DI
00819837020880
Brand
Sagittae
Company
SPINEEX, INC.
Model
025-030-13
Catalog number
025-030-13
Device description
Trial, 13 mm Height
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
00819837020880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819837020880008198370208808198370208800819837020880

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height13Millimeter

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

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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
07613153046400AVS TLStryker CorporationMAX2015-09-14
07613153046417AVS TLStryker CorporationMAX2015-09-14
07613153046424AVS TLStryker CorporationMAX2015-09-14
07613153046431AVS TLStryker CorporationMAX2015-09-14
07613153046448AVS TLStryker CorporationMAX2015-09-14