PICASSO MIS Spinal System

Primary DI
00841732159822
Brand
PICASSO MIS Spinal System
Company
CTL Medical Corporation
Model
016.6200.L
Device description
Percutaneous Straight Rod, D6.0 x L200mm
Published
2023-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K120714000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120714000PICASSO MIS SPINAL FIXATION SYSTEMAccel Spine2012-08-09NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732159822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732159822008417321598228417321598220841732159822

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

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
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
00841732169272PICASSO MIS Spinal System016.31602026-07-24
00841732169289PICASSO MIS Spinal System016.31702026-07-24
00841732169296PICASSO MIS Spinal System016.31802026-07-24
00841732169302PICASSO MIS Spinal System016.31902026-07-24
00841732169319PICASSO MIS Spinal System016.32002026-07-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841732169272PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169272PICASSO MIS Spinal SystemCTL Medical CorporationMNI2026-07-24
00841732169272PICASSO MIS Spinal SystemCTL Medical CorporationMNH2026-07-24
00841732169289PICASSO MIS Spinal SystemCTL Medical CorporationMNH2026-07-24
00841732169289PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169289PICASSO MIS Spinal SystemCTL Medical CorporationMNI2026-07-24
00841732169296PICASSO MIS Spinal SystemCTL Medical CorporationMNH2026-07-24
00841732169296PICASSO MIS Spinal SystemCTL Medical CorporationMNI2026-07-24
00841732169296PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169302PICASSO MIS Spinal SystemCTL Medical CorporationMNH2026-07-24
00841732169302PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169302PICASSO MIS Spinal SystemCTL Medical CorporationMNI2026-07-24
00841732169319PICASSO MIS Spinal SystemCTL Medical CorporationMNH2026-07-24
00841732169319PICASSO MIS Spinal SystemCTL Medical CorporationMNI2026-07-24
00841732169319PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
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10888857598287Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
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