FDA.reportPublic FDA data

Anatomical Model Original

Primary DI
17350086550433
Brand
Anatomical Model Original
Company
Ossdsign AB
Model
Whole skull
Device description
OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient’s unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set. (510(k) no. K190523)
Published
2020-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
PJNFiller, Bone Void, Non-Alterable Compound For Cranioplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJNFiller, Bone Void, Non-Alterable Compound For CranioplastyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190523000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190523000Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant TrialOssdsign AB2019-10-10PJN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17350086550433PackageGS11In Commercial Distribution
07350086550436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1735008655043317350086550433
07350086550436073500865504367350086550436

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made organ/bone anatomy modelA model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier, and may be sterilized prior to use in sterile fields.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius34 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
350354370
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350086550238OSSDSIGN Cranioplug14 mm, 6 fixation-points2019-06-05
07350086550245OSSDSIGN Cranioplug11 mm, 2 fixation-points2019-06-05
07350086550252OSSDSIGN Cranioplug11 mm, 6 fixation-points2019-06-05
07350086550221OSSDSIGN Cranioplug14 mm, 2 fixation-pointsn/a2019-06-05
07350086550115OSSDSIGN Cranial PSIXL1010112017-05-11
07350086550429Anatomical Model OriginalHalf skull2020-07-03
07350086550436Anatomical Model OriginalWhole skull2020-07-03
07350086550504Anatomical Model ModifiedHalf skull2020-07-03
07350086550511Anatomical Model ModifiedWhole skull2020-07-03
07350086550528Plastic Drawing GuideS2020-01-22
07350086550535Plastic Drawing GuideM2020-01-22
07350086550542Plastic Drawing GuideL2020-01-22
07350086550559Plastic Drawing GuideXL2020-01-22
07350086550566Cranial Implant TrialS2020-01-22
07350086550573Cranial Implant TrialM2020-01-22
07350086550580Cranial Implant TrialL2020-01-22
07350086550597Cranial Implant TrialXL2020-01-22
07350086550085OSSDSIGN Cranial PSIS2017-05-11
07350086550092OSSDSIGN Cranial PSIM1010092017-05-11
07350086550108OSSDSIGN Cranial PSIL1010102017-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860003416303ClearFit VDI StandardLONGEVITI NEURO SOLUTIONS LLCPJN2025-02-19
00860003416310ClearFit VDI LargeLONGEVITI NEURO SOLUTIONS LLCPJN2025-02-19
00855113008104ClearFitLONGEVITI NEURO SOLUTIONS LLCPJN2023-04-13
00855113008111ClearFitLONGEVITI NEURO SOLUTIONS LLCPJN2023-03-27
00855113008128ClearFitLONGEVITI NEURO SOLUTIONS LLCPJN2023-03-27
00855113008135ClearFitLONGEVITI NEURO SOLUTIONS LLCPJN2023-03-27
00855113008142ClearFitLONGEVITI NEURO SOLUTIONS LLCPJN2023-03-27
00855113008159ClearFitLONGEVITI NEURO SOLUTIONS LLCPJN2023-03-27
00855113008272ClearFitLONGEVITI NEURO SOLUTIONS LLCPJN2023-03-27
00855113008289ClearFitLONGEVITI NEURO SOLUTIONS LLCPJN2023-03-27
00855113008296ClearFitLONGEVITI NEURO SOLUTIONS LLCPJN2023-03-27
00855113008494ClearFitLONGEVITI NEURO SOLUTIONS LLCPJN2023-03-27
00855113008500ClearFitLONGEVITI NEURO SOLUTIONS LLCPJN2023-03-27
00855113008548ClearFitLONGEVITI NEURO SOLUTIONS LLCPJN2023-03-27
00855113008555ClearFitLONGEVITI NEURO SOLUTIONS LLCPJN2023-03-27
07350086550429Anatomical Model OriginalOssdsign ABPJN2020-07-03
07350086550436Anatomical Model OriginalOssdsign ABPJN2020-07-03
07350086550504Anatomical Model ModifiedOssdsign ABPJN2020-07-03
07350086550511Anatomical Model ModifiedOssdsign ABPJN2020-07-03
17350086550426Anatomical Model OriginalOssdsign ABPJN2020-07-03
17350086550501Anatomical Model ModifiedOssdsign ABPJN2020-07-03
17350086550518Anatomical Model ModifiedOssdsign ABPJN2020-07-03
00855113008098ClearFitLONGEVITI NEURO SOLUTIONS LLCPJN2020-03-09
90855113008084ClearFitLONGEVITI NEURO SOLUTIONS LLCPJN2020-03-09
07350086550528Plastic Drawing GuideOssdsign ABPJN2020-01-22
07350086550535Plastic Drawing GuideOssdsign ABPJN2020-01-22
07350086550542Plastic Drawing GuideOssdsign ABPJN2020-01-22
07350086550559Plastic Drawing GuideOssdsign ABPJN2020-01-22
07350086550566Cranial Implant TrialOssdsign ABPJN2020-01-22
07350086550573Cranial Implant TrialOssdsign ABPJN2020-01-22