Primary Device ID | B278PN3208904N0 |
NIH Device Record Key | f40f3a2a-7a54-42b2-ad38-d70237085f9a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | My3D® Personalized Pelvic Reconstruction |
Version Model Number | PN-32089-04N |
Catalog Number | PN-32089-04N |
Company DUNS | 080254074 |
Company Name | ONKOS SURGICAL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B278PN3208904N0 [Primary] |
LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-05-24 |
Device Publish Date | 2023-05-16 |
B278DG6512004N0 | FLEXIBLE 120MM DEPTH GAUGE |
B278DVRGDMD04N0 | RIGID DRILL/SCREW SHAFT, MODULAR |
B278DVFLXMD04N0 | FLEXIBLE DRILL/SCREW SHAFT, MODULAR |
B278SF6500004N0 | 6.5MM SCREW FORCEPS |
B278HDBP33204N0 | BALL PUSHER |
B278EX3506504N0 | CONICAL SCREW EXTRACTOR, 4.5 -7.0MM SCREWS, AO CONNECTION |
B278TP65180040 | 6.5MM x 180MM CANCELLOUS BONE SCREW TAP, AO CONNECTOR |
B278TP6505004N0 | 6.5MM x 50MM CANCELLOUS BONE SCREW TAP, BAYONET CONNETOR |
B278TP6502504N0 | 6.5MM x 25MM CANCELLOUS BONE SCREW TAP, BAYONET CONNECTOR |
B278PVGUIDE04N0 | Customized Pelvic Guide |
B278PVAPRCN04M0 | Advanced Pelvic Reconstruction Implant |
B278PVACREC04M0 | Acetabular Reconstruction Implant |
B278HDSP03604N0 | Pelvic Impactor |
B278HD35TRQ04N0 | TORQUE LIMITING ZSJ HALL HANDLE, 35IN-LBS |
B278DGCS02004N0 | 4.3MM CANCELLOUS SCREW DRILL GUIDE |
B278AMM3DMD04N0 | Anatomic Model |
B278AMC3DMD04N0 | Clear Anatomic Model |
B278PN3208904N0 | 3.2 x 89MM Smooth Trocar Tip Pin |
B278DR4350N04N0 | 4.3MM x 50MM Non-Sterile Modular Drill Bit |
B278DR432NS04N0 | 4.3MM x 200MM Non-Sterile Calibrated Drill Bit |
B278DR4325N04N0 | 4.3MM x 25MM Non-Sterile Modular Drill Bit |
B278LS5003504M0 | Locking Cortical Bone Screw 5.0x35MM |
B278LS5003004M0 | Locking Cortical Bone Screw 5.0x30MM |
B278LS5001604M0 | Locking Cortical Bone Screw 5.0x16MM |
B278LS5001504M0 | Locking Cortical Bone Screw 5.0x15MM |
B278LS5001404M0 | Locking Cortical Bone Screw 5.0x14MM |
B278LS5001204M0 | Locking Cortical Bone Screw 5.0x12MM |
B278LS5001004M0 | Locking Cortical Bone Screw 5.0x10MM |
B278DR4320004N0 | 4.3 x 200MM Calibrated Drill Bit |
B278DR4305004N0 | 4.3 x 50MM Modular Drill Bit |
B278DR4302504N0 | 4.3 x 25MM Modular Drill Bit |
B278LS5009504M0 | Locking Cortical Bone Screw 5.0x95MM |
B278LS5009004M0 | Locking Cortical Bone Screw 5.0x90MM |
B278LS5008504M0 | Locking Cortical Bone Screw 5.0x85MM |
B278LS5008004M0 | Locking Cortical Bone Screw 5.0x80MM |
B278LS5007504M0 | Locking Cortical Bone Screw 5.0x75MM |
B278LS5007004M0 | Locking Cortical Bone Screw 5.0x70MM |
B278LS5006504M0 | Locking Cortical Bone Screw 5.0x65MM |
B278LS5006004M0 | Locking Cortical Bone Screw 5.0x60MM |
B278LS5005504M0 | Locking Cortical Bone Screw 5.0x55MM |
B278LS5005004M0 | Locking Cortical Bone Screw 5.0x50MM |
B278LS5004804M0 | Locking Cortical Bone Screw 5.0x48MM |
B278LS5004504M0 | Locking Cortical Bone Screw 5.0x45MM |
B278LS5004404M0 | Locking Cortical Bone Screw 5.0x44MM |
B278LS5004204M0 | Locking Cortical Bone Screw 5.0x42MM |
B278LS5004004M0 | Locking Cortical Bone Screw 5.0x40MM |
B278LS5003804M0 | Locking Cortical Bone Screw 5.0x38MM |
B278LS5003604M0 | Locking Cortical Bone Screw 5.0x36MM |
B278LS5003404M0 | Locking Cortical Bone Screw 5.0x34MM |
B278LS5003204M0 | Locking Cortical Bone Screw 5.0x32MM |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MY3D 87981909 5904299 Live/Registered |
Onkos Surgical, Inc. 2017-04-24 |
MY3D 87422570 not registered Live/Pending |
Onkos Surgical, Inc. 2017-04-24 |
MY3D 86386459 5176789 Live/Registered |
David G. Capper 2014-09-05 |
MY3D 85120654 not registered Dead/Abandoned |
HASBRO, INC. 2010-09-01 |