FDA.reportPublic FDA data

ENDOSKELETON® TL

Primary DI
00191375052463
Brand
ENDOSKELETON® TL
Company
TITAN SPINE, LLC
Model
1000-0133
Catalog number
1000-0133
Device description
Microsurgery Curette Stirrup Straight
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
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
K140055000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140055000ENDOSKELETON(R) TL INTERBODY FUSION DEVICETitan Spine, LLC2014-07-02MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191375052463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191375052463001913750524631913750524630191375052463

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. 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

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Primary DI, Brand, Company table
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