FDA.reportPublic FDA data

Cavetto

Primary DI
00841508105497
Brand
Cavetto
Company
NEUROSTRUCTURES, INC
Model
30-90-006P-141606
Device description
Trial With Handle Peak to Peak 14x16x06
Published
2016-01-11
Public version status
Update
Distribution status
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841508105497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841508105497008415081054978415081054970841508105497

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8003526103customerservice@neurostructures.com

Regulatory Flags#

DUNS number
079391677
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841508100003Tempus™10-01-0122016-03-09
00841508100010Tempus™10-01-0142015-09-17
00841508100027Tempus™10-01-0162015-09-17
00841508100034Tempus™10-01-0182015-09-17
00841508100041Tempus™10-01-0202015-09-17
00841508100058Tempus™10-01-0222015-09-17
00841508100065Tempus™10-01-0242015-09-17
00841508100072Tempus™10-01-0262015-09-17
00841508100089Tempus™10-02-0242015-09-17
00841508100096Tempus™10-02-0262015-09-17
00841508100102Tempus™10-02-0282015-09-17
00841508100119Tempus™10-02-0302015-09-17
00841508100126Tempus™10-02-0322015-09-17
00841508100133Tempus™10-02-0342015-09-17
00841508100140Tempus™10-02-0372015-09-17
00841508100157Tempus™10-02-0402015-09-17
00841508100164Tempus™10-02-0432015-09-17
00841508100171Tempus™10-02-0462015-09-17
00841508100188Tempus™10-03-0392015-09-17
00841508100195Tempus™10-03-0422015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.ODP2026-09-22
07613327503968Aero-CStryker CorporationODP2019-12-18
10888857461819CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
07613327353921Aero-CStryker CorporationODP2018-06-28
07613327353938Aero-CStryker CorporationODP2018-06-28
07613327353945Aero-CStryker CorporationODP2018-06-28
07613327353952Aero-CStryker CorporationODP2018-06-28
07613327353976Aero-CStryker CorporationODP2018-06-28
07613327347036Tritanium CStryker CorporationODP2017-09-18
07613327347050Tritanium CStryker CorporationODP2017-09-18
07613327347067Tritanium CStryker CorporationODP2017-09-18
07613327347098Tritanium CStryker CorporationODP2017-09-18
07613327347159Tritanium CStryker CorporationODP2017-09-18
07613327347197Tritanium CStryker CorporationODP2017-09-18
07613327347296Tritanium CStryker CorporationODP2017-09-18
07613327347333Tritanium CStryker CorporationODP2017-09-18
07613327347357Tritanium CStryker CorporationODP2017-09-18
07613327347364Tritanium CStryker CorporationODP2017-09-18
07613327349535Tritanium CStryker CorporationODP2017-09-18
07613327360035Tritanium CStryker CorporationODP2017-09-18
07613327360103Tritanium CStryker CorporationODP2017-09-18
07613327360257Tritanium CStryker CorporationODP2017-09-18
07613327360363Tritanium CStryker CorporationODP2017-09-18
07613327360370Tritanium CStryker CorporationODP2017-09-18
07613327360516Tritanium CStryker CorporationODP2017-09-18
07613252602774AVS Anchor-LStryker CorporationODP2016-09-24