FDA.reportPublic FDA data

ENDOSKELETON TC

Primary DI
M682520010010
Brand
ENDOSKELETON TC
Company
TITAN SPINE, LLC
Model
5200-1001
Catalog number
5200-1001
Device description
INSERTER
Published
2016-09-17
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
ODPIntervertebral fusion device with bone graft, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100889000ENDOSKELETON TCTitan Spine, LLC2010-07-29ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M682520010010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Inch

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
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18257200030828CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030842CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030866CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030880CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030903CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030927CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030965CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031023CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031047CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031061CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031085CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031108CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031122CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031146CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031160CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031184CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031207CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031221CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031245CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031269CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031283CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031306CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031320CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031344CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031368CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031382CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17