FDA.reportPublic FDA data

IPS

Primary DI
00888118145857
Brand
IPS
Company
KLS-Martin L.P.
Model
60-011-17-09-LP
Device description
IMPLANT, 2 QUADRANT, PREPROSTHETIC, LOCKING, REMOVABLE MUA, LP, CAN, TI-6AL-4V
Published
2026-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELEIMPLANT, SUBPERIOSTEAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELEImplant, SubperiostealDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118145857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118145857008881181458578881181458570888118145857

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made cranial bone prosthesisAn implantable device intended to repair a defect of the cranium or mandible that is designed and constructed with specific characteristics (e.g., size, shape, material) as prescribed by a healthcare provider for a specified patient. It is typically manufactured from a three-dimensional (3-D) model based on computed tomography (CT) images and made of plastic [e.g., ultrahigh molecular weight polyethylene (UHMWPE), polyetheretherketone (PEEK)] and/or metal [e.g., titanium (Ti)]. The device may be used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease, or for cosmetic/aesthetic purposes.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
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
00888118145819IPS60-011-13-09-LP2026-10-01
00888118145826IPS60-011-14-09-LP2026-10-01
00888118145833IPS60-011-15-09-LP2026-10-01
00888118145840IPS60-011-16-09-LP2026-10-01
00888118145864IPS60-011-18-09-LP2026-10-01
00888118036261LEVEL ONE CMF25-038-30-092016-03-24
00888118036278LEVEL ONE CMF25-038-35-092016-03-24
00888118036285LEVEL ONE NEURO25-040-25-092016-03-24
00888118036292LEVEL ONE NEURO, STERILE25-040-25-712016-03-23
00888118036339LEVEL ONE CMF25-040-35-092016-03-24
00888118036346LEVEL ONE CMF25-040-40-092016-03-24
00888118036360LEVEL ONE NEURO25-042-02-092016-03-24
00888118036391LEVEL ONE NEURO25-042-05-092016-03-24
00888118036483LEVEL ONE CMF, STERILE25-042-20-712016-03-23
00888118092618LEVEL ONE CMF25-043-06-092016-03-24
00888118155498IPS60-500-15-092026-09-28
00888118155504IPS60-500-15-09-LP2026-09-28
00888118155511IPS60-500-15-09-PP2026-09-28
00888118155528IPS60-500-17-092026-09-28
00888118155535IPS60-500-17-09-LP2026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118145819IPSKLS-Martin L.P.ELE2026-10-01
00888118145826IPSKLS-Martin L.P.ELE2026-10-01
00888118145833IPSKLS-Martin L.P.ELE2026-10-01
00888118145840IPSKLS-Martin L.P.ELE2026-10-01
00888118145864IPSKLS-Martin L.P.ELE2026-10-01
00888118150646IPSKLS-Martin L.P.ELE2026-05-25
00888118140968IPSKLS-Martin L.P.ELE2025-11-26
00888118140975IPSKLS-Martin L.P.ELE2025-11-26
00888118140982IPSKLS-Martin L.P.ELE2025-11-26
00888118141804IPSKLS-Martin L.P.ELE2025-11-26
00888118141811IPSKLS-Martin L.P.ELE2025-11-26
00888118141828IPSKLS-Martin L.P.ELE2025-11-26
00888118148742IPSKLS-Martin L.P.ELE2025-11-26
00888118148759IPSKLS-Martin L.P.ELE2025-11-26
00888118148766IPSKLS-Martin L.P.ELE2025-11-26
00888118148773IPSKLS-Martin L.P.ELE2025-11-26
00888118148780IPSKLS-Martin L.P.ELE2025-11-26
00888118148797IPSKLS-Martin L.P.ELE2025-11-26
00888118148803IPSKLS-Martin L.P.ELE2025-11-26
00888118148810IPSKLS-Martin L.P.ELE2025-11-26
00888118148827IPSKLS-Martin L.P.ELE2025-11-26
00888118148834IPSKLS-Martin L.P.ELE2025-11-26
00888118145024IPSKLS-Martin L.P.ELE2024-11-25
00888118145031IPSKLS-Martin L.P.ELE2024-11-25
00888118145048IPSKLS-Martin L.P.ELE2024-11-25
00888118145055IPSKLS-Martin L.P.ELE2024-11-25
00888118145062IPSKLS-Martin L.P.ELE2024-11-25
00888118145079IPSKLS-Martin L.P.ELE2024-11-25
00888118141835IPSKLS-Martin L.P.ELE2023-08-24
00888118141842IPSKLS-Martin L.P.ELE2023-08-24