FDA.reportPublic FDA data

Sagittae

Primary DI
00819837021085
Brand
Sagittae
Company
SPINEEX, INC.
Model
903-030-XX
Catalog number
903-030-XX
Device description
MIS Handle
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
00819837021085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819837021085008198370210858198370210850819837021085

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5135736165info@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
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