FDA.reportPublic FDA data

IPS

Primary DI
00888118141804
Brand
IPS
Company
KLS-Martin L.P.
Model
60-004-51-09-LP
Device description
IMPLANT, 1 QUADRANT, PREPROSTHETIC, LOCKING, REMOVABLE MUA, LP, TI-6AL-4V
Published
2025-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
00888118141804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118141804008881181418048881181418040888118141804

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
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118150288LEVEL ONE CMF, STERILE50-280-00-712026-10-21
00888118150295LEVEL ONE CMF, STERILE50-280-03-712026-10-21
00888118150301LEVEL ONE CMF, STERILE50-280-05-712026-10-21
00888118150318LEVEL ONE CMF, STERILE50-280-07-712026-10-21
00888118150325LEVEL ONE CMF, STERILE50-280-09-712026-10-21
00888118150332LEVEL ONE CMF, STERILE50-280-11-712026-10-21
00888118150349LEVEL ONE CMF, STERILE50-282-00-712026-10-21
00888118150356LEVEL ONE CMF, STERILE50-282-03-712026-10-21
00888118150363LEVEL ONE CMF, STERILE50-282-05-712026-10-21
00888118150370LEVEL ONE CMF, STERILE50-282-07-712026-10-21
00888118150387LEVEL ONE CMF, STERILE50-282-09-712026-10-21
00888118150394LEVEL ONE CMF, STERILE50-282-11-712026-10-21
00888118150400LEVEL ONE CMF, STERILE50-302-09-712026-10-21
00888118150417LEVEL ONE CMF, STERILE50-302-11-712026-10-21
00888118154910LEVEL ONE CMF25-874-11-612026-10-21
00888118154927LEVEL ONE CMF25-874-11-912026-10-21
00888118154934LEVEL ONE CMF25-874-15-912026-10-21
00888118154941LEVEL ONE CMF25-874-15-612026-10-21
00888118154958LEVEL ONE CMF, STERILE25-874-11-712026-10-21
00888118154965LEVEL ONE CMF, STERILE25-874-15-712026-10-21

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
00888118145857IPSKLS-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
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