FDA.reportPublic FDA data

EmbedMed

Primary DI
00860009815780
Brand
EmbedMed
Company
3D LIFEPRINTS UK LTD
Model
OTHSG-S
Device description
Sterile Patient-specific, Orthopedic Surgical Guide
Published
2026-03-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
PBFOrthopaedic Surgical Planning And Instrument Guides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
PBFOrthopaedic Surgical Planning And Instrument GuidesOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009815780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009815780008600098157808600098157800860009815780

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made orthopaedic/craniofacial surgical guideA custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.

Regulatory Flags#

DUNS number
220777297
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
00860015267801EmbedMedCMFSG-S2026-03-30
00860009815728EmbedMedCMFSG2023-05-23
00860009815759EmbedMedOTHSG2023-05-22
00860009815797EmbedMedOTHAMS-S2026-03-30
00860015267818EmbedMedCMFAMS-S2026-03-30
00860009815711EmbedMedCMFAMFEUS2023-05-23
00860009815735EmbedMedCMFDAM2023-05-23
00860009815704EmbedMedCMFAMNS2023-02-20
00860009815766EmbedMedOTHAMFEUS2023-05-23
00860009815773EmbedMedOTHAMNS2023-05-23
00860009815742EmbedMedOTHDAM2023-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00810007633282AccuStride SystemMedcadPBF2025-06-30
00810007633299AccuStride SystemMedcadPBF2025-06-30
00810007633305AccuStride SystemMedcadPBF2025-06-30
00810007633312AccuStride SystemMedcadPBF2025-06-30
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00810007633244AccuStride SystemMedcadPBF2025-06-10
00810111224680TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2025-05-22
00810111224697TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2025-05-22
00081000763324AccuStride SystemMedcadPBF2025-05-05
00810007633251AccuStride SystemMedcadPBF2025-05-05
00810007633268AccuStride SystemMedcadPBF2025-05-05
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00810111223553TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-15
00810111223560TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-15
00810111223577TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-15
00810111223584TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-15
00810111223447TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-14
00810111223454TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-14
00810111223478TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-14
00810111223621TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-14