FDA.reportPublic FDA data

TransLoc 3D

Primary DI
00850026642216
Brand
TransLoc 3D
Company
Foundation Fusion Solutions, LLC
Model
T03-01
Device description
Ratcheting T-Handle
Published
2023-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211496000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211496000TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)2022-07-27OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850026642216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850026642216008500266422168500266422160850026642216

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-743-8736bob@cornerloc.com

Regulatory Flags#

DUNS number
105361659
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850026642179TransLoc 3D S24-092023-10-17
00850026642308TransLoc 3D TS85-602023-10-31
00850026642315TransLoc 3D TS95-352023-10-31
00850026642322TransLoc 3D TS95-402023-10-31
00850026642339TransLoc 3D TS95-452023-10-31
00850026642346TransLoc 3D TS95-502023-10-31
00850026642353TransLoc 3D TS95-552023-10-31
00850026642360TransLoc 3D TS95-602023-10-31
00850026642001TransLoc 3D T05-012023-10-17
00850026642018TransLoc 3D T05-022023-10-17
00850026642100TransLoc 3D S01-012023-10-17
00850026642117TransLoc 3D S01-022023-10-17
00850026642124TransLoc 3D S02-012023-10-17
00850026642131TransLoc 3D S03-012023-10-17
00850026642148TransLoc 3D S04-012023-10-17
00850026642155TransLoc 3D S06-012023-10-17
00850026642162TransLoc 3D S06-022023-10-17
00850026642193TransLoc 3D T01-022023-10-17
00850026642209TransLoc 3D T02-402023-10-17
00850026642223TransLoc 3D T04-012023-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196449010196Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449010288Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035243Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035250Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035267Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035281Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035298Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035304Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035311Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035328Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035335Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035366Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035380Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035397Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035441Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035465Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035472Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00810094692698Modular Frog EyesTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
00810094692704Distal Femoral Cut Block ConnectorTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
00810094692933Magnet Spacer, 5mmTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
04052536123728mamboUlrich GmbH & Co. KGLXH2026-06-09
08809945870578BENCOXCorentec Co., LtdLXH2026-06-09
04052536085668neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162048neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162079neon3Ulrich GmbH & Co. KGLXH2026-06-08
00198506091445ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-05
00199150076161Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-05
00840311263882Streamline OCTXtant Medical Holdings, Inc.LXH2026-06-04
00198506091179ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-03
08698940967426SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03