FDA.reportPublic FDA data

PICASSO II MIS Spinal System

Primary DI
00841732119086
Brand
PICASSO II MIS Spinal System
Company
CTL Medical Corporation
Model
119.1755
Device description
PICASSO-II™ Percutaneous Polyaxial Screw, Semi-Closed 127mm, D7.5xL55mm
Published
2017-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140219000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140219000PICASSO II MIS SPINAL SYSTEMAccel Spine2014-04-14NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732119086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732119086008417321190868417321190860841732119086

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(214)545-5820schedule@ctlamedica.com

Regulatory Flags#

DUNS number
080138504
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841732163447VALEO C Spacer System91.002.40012023-09-30
00841732163454VALEO C Spacer System91.002.40022023-09-30
00841732163461VALEO C Spacer System91.002.40032023-09-30
00841732128231VALEO VBR91.009.56512023-09-27
00841732128248VALEO VBR91.009.56522023-09-27
00841732145511VALEO C+CSC with Lumen Interbody Fusion Device11.209.17072023-09-19
00841732145528VALEO C+CSC with Lumen Interbody Fusion Device11.209.17082023-09-19
00841732145535VALEO C+CSC with Lumen Interbody Fusion Device11.209.17092023-09-19
00841732145542VALEO C+CSC with Lumen Interbody Fusion Device11.209.17102023-09-19
00841732154766VALEO C+CSC with Lumen Interbody Fusion Device11.209.11082023-09-19
00841732154773VALEO C+CSC with Lumen Interbody Fusion Device11.209.11092023-09-19
00841732154780VALEO C+CSC with Lumen Interbody Fusion Device11.209.11102023-09-19
00841732154797VALEO C+CSC with Lumen Interbody Fusion Device11.209.11112023-09-19
00841732154803VALEO C+CSC with Lumen Interbody Fusion Device11.209.17052023-09-19
00841732154810VALEO C+CSC with Lumen Interbody Fusion Device11.209.17062023-09-19
00841732154865VALEO C+CSC with Lumen Interbody Fusion Device11.209.17112023-09-19
00841732149847TAURUS Pedicle Screw System51-1000-0012023-09-15
00841732149854TAURUS Pedicle Screw System51-1000-0022023-09-15
00841732150614GENERIC Surgical Instruments50-1000-0042023-09-15
00841732150621TAURUS Pedicle Screw System51-0000-0002023-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115932508Tower Guide STPREMIA SPINE LTDMNI2026-07-23
07290115932508Tower Guide STPREMIA SPINE LTDMNH2026-07-23
07290115932508Tower Guide STPREMIA SPINE LTDNKB2026-07-23
M719GL201TL0SIros-XGenesys Orthopedics Systems LLCNKB2026-07-23
00840019935319Reform TiPRECISION SPINE, INC.NKB2019-10-07
00840019935364Reform TiPRECISION SPINE, INC.NKB2019-10-07
00840019934800Reform TiPRECISION SPINE, INC.NKB2019-10-04
00840019934817Reform TiPRECISION SPINE, INC.NKB2019-10-04
00840019934824Reform TiPRECISION SPINE, INC.NKB2019-10-04
00840019934831Reform TiPRECISION SPINE, INC.NKB2019-10-04
00840019934725Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934732Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934749Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934756Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934763Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934770Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934787Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934794Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934251Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934268Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934275Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934282Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934299Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934305Reform TIPRECISION SPINE, INC.NKB2019-09-10
00840019934312Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934329Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934336Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934343Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934350Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934367Reform TIPRECISION SPINE, INC.NKB2019-09-10