FDA.reportPublic FDA data

IPS

Primary DI
00888118140487
Brand
IPS
Company
KLS-Martin L.P.
Model
60-000-79-09-LP
Device description
IMPLANT, ORBITAL, 00079, LP, TI-6AL-4V
Published
2023-03-22
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZJDRIVER, WIRE, AND BONE DRILL, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118140487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118140487008881181404878881181404870888118140487

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
00888118131782LEVEL ONE EXTREMITY26-066-60-092026-05-25
00888118131799LEVEL ONE EXTREMITY26-066-70-092026-05-25
00888118144928LEVEL ONE EXTREMITY26-950-40-072026-05-25
00888118145284PURE PECTUS24-070-60-092026-05-25
00888118145291PURE PECTUS24-070-62-092026-05-25
00888118150240PURE PECTUSCTM-241-100-012026-05-25
00888118150257PURE PECTUSCTM-241-101-012026-05-25
00888118150264PURE PECTUSCTM-241-200-012026-05-25
00888118150448IXOSCTM-263-100-012026-05-25
00888118150455IXOSCTM-263-101-012026-05-25
00888118150462IXOSCTM-263-202-012026-05-25
00888118150479IXOSCTM-263-202-022026-05-25
00888118150486IXOSCTM-263-202-032026-05-25
00888118150493IXOSCTM-263-202-042026-05-25
00888118150646IPS60-011-42-09-LP2026-05-25
00888118153029L1 STERNALCTM-242-302-012026-05-25
00888118153050IXOSCTM-263-203-012026-05-25
00888118153067IXOSCTM-263-203-022026-05-25
00888118153074IXOSCTM-263-203-032026-05-25
00888118153081IXOSCTM-263-203-042026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118154231IPSKLS-Martin L.P.DZJ2026-05-25
00888118149572IPSKLS-Martin L.P.DZJ2026-02-23
00888118149589IPSKLS-Martin L.P.DZJ2026-02-23
00888118149626IPSKLS-Martin L.P.DZJ2026-02-23
00888118149336IPSKLS-Martin L.P.DZJ2025-11-26
05420060380839TRUMATCHMaterialise NVDZJ2025-09-11
05420060380846TRUMATCHMaterialise NVDZJ2025-09-11
05420060380853TRUMATCHMaterialise NVDZJ2025-09-11
05420060380860TRUMATCHMaterialise NVDZJ2025-09-11
05420060380877TRUMATCHMaterialise NVDZJ2025-09-11
05420060380884TRUMATCHMaterialise NVDZJ2025-09-11
05420060380891TRUMATCHMaterialise NVDZJ2025-09-11
05420060380907TRUMATCHMaterialise NVDZJ2025-09-11
00840124519633PolyLockFUSION ORTHOPEDICS, LLCDZJ2025-05-15
00840124519640PolyLockFUSION ORTHOPEDICS, LLCDZJ2025-05-15
00840124519893PolyLock MidfootFUSION ORTHOPEDICS, LLCDZJ2025-05-15
00840124519909PolyLock MidfootFUSION ORTHOPEDICS, LLCDZJ2025-05-15
00840124519916PolyLock MidfootFUSION ORTHOPEDICS, LLCDZJ2025-05-15
00888118145086IPSKLS-Martin L.P.DZJ2025-04-22
00888118145093IPSKLS-Martin L.P.DZJ2025-04-22
00888118145543IPSKLS-Martin L.P.DZJ2025-04-22
00888118145550IPSKLS-Martin L.P.DZJ2025-04-22
00888118145567IPSKLS-Martin L.P.DZJ2025-04-22
00860012759446TECHFITTechfit Digital Surgery, Inc.DZJ2025-03-17
00860012759453TECHFITTechfit Digital Surgery, Inc.DZJ2025-03-17
00860012759460TECHFITTechfit Digital Surgery, Inc.DZJ2025-03-17
05420060380747TRUMATCHMaterialise NVDZJ2025-02-28
05420060380754TRUMATCHMaterialise NVDZJ2025-02-28
05420060380761TRUMATCHMaterialise NVDZJ2025-02-28
00840124514416FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCDZJ2024-12-04