FDA.reportPublic FDA data

ENDOSKELETON TL RETRACTOR

Primary DI
M68279001000020
Brand
ENDOSKELETON TL RETRACTOR
Company
TITAN SPINE, LLC
Model
7900-1000-02
Catalog number
7900-1000-02
Device description
Probe
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
GXZELECTRODE, NEEDLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063729000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063729000DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00Technomed Europe2007-08-21GXZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M68279001000020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system, reusableA frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14Inch

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
08718375869062AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869093AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869123AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375868102Consolidated Neuro SupplyTechnomed Engineering B.V.GXZ2021-06-02
08718375867129NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867143NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867167NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867181NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867204NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867228NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867242NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867266NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867280NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867303NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867556Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867570Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867884Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867891Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867907Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867914Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867921Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867938Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867945Technomed EuropeTechnomed Engineering B.V.GXZ2021-01-20
08718375867969Neurosign V4Technomed Engineering B.V.GXZ2021-01-12
08718375867983Neurosign V4Technomed Engineering B.V.GXZ2021-01-12
08718375867327Technomed EuropeTechnomed Engineering B.V.GXZ2020-12-08
08718375867341Technomed EuropeTechnomed Engineering B.V.GXZ2020-12-08
08718375867365Technomed EuropeTechnomed Engineering B.V.GXZ2020-12-08
08718375866672Neurosign V4Technomed Engineering B.V.GXZ2020-07-22
08718375867785Technomed EuropeTechnomed Engineering B.V.GXZ2020-07-22