FDA.reportPublic FDA data

ENDOSKELETON® TAS

Primary DI
00191375051404
Brand
ENDOSKELETON® TAS
Company
TITAN SPINE, LLC
Model
2900-1051
Catalog number
2900-1051
Device description
35mm Screw Caddy
Published
2019-11-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111626000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111626000ENDOSKELETON(R) TASTitan Spine, LLC2011-09-09OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191375051404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191375051404001913750514041913750514040191375051404

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(262)242-7801productinfo@titanspine.com

Regulatory Flags#

DUNS number
623316978
Device count
1
DM exempt
true
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
M682210701100Endoskeleton TA2107-01102107-01102015-09-17
M682210701110Endoskeleton TA2107-01112107-01112015-09-17
M682210701120Endoskeleton TA2107-01122107-01122015-09-17
M682210701130Endoskeleton TA2107-01132107-01132015-09-17
M682210701140Endoskeleton TA2107-01142107-01142015-09-17
M682210701150Endoskeleton TA2107-01152107-01152015-09-17
M682210701160Endoskeleton TA2107-01162107-01162015-09-17
M682210701170Endoskeleton TA2107-01172107-01172015-09-17
M682210701180Endoskeleton VBR2107-01182107-01182015-09-17
M682210701200Endoskeleton VBR2107-01202107-01202015-09-17
M682210702100Endoskeleton TA2107-02102107-02102015-09-17
M682210702110Endoskeleton TA2107-02112107-02112015-09-17
M682210702120Endoskeleton TA2107-02122107-02122015-09-17
M682210702130Endoskeleton TA2107-02132107-02132015-09-17
M682210702140Endoskeleton TA2107-02142107-02142015-09-17
M682210702150Endoskeleton TA2107-02152107-02152015-09-17
M682210702160Endoskeleton TA2107-02162107-02162015-09-17
M682210702170Endoskeleton TA2107-02172107-02172015-09-17
M682210702180Endoskeleton VBR2107-02182107-02182015-09-17
M682210702200Endoskeleton VBR2107-02202107-02202015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889981217204MeridianSeaspine Orthopedics CorporationOVD2022-08-25
10889981230906RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230913RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230920RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230937RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230944RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230951RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230968RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230975RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230982RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230999RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231002RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231019RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231026RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231033RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231248RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231255RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231262RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231279RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981214395MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214401MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214418MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214425MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214432MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214449MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214456MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214463MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214470MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214487MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214616MeridianSeaspine Orthopedics CorporationOVD2020-12-30