| Primary Device ID | M555208200080 |
| NIH Device Record Key | 418cd8e1-5f33-4eb7-865b-5ad9430beb30 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Preference 2 |
| Version Model Number | B |
| Catalog Number | 20-8200-080 |
| Company DUNS | 028629553 |
| Company Name | AMEDICA CORPORATION |
| 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 | false |
| 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 |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.2 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M555208200080 [Primary] |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
[M555208200080]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-11-14 |
| Device Publish Date | 2017-12-29 |
| M555289000320 | Complex Spine System Hook, Transverse Process, Right 5.5 |
| M555289000310 | Complex Spine System Hook, Transverse Process, Left 5.5 |
| M555289000300 | Complex Spine System Hook, Transverse Process 5.5 |
| M555289000210 | Complex Spine System Hook, Pedicle, Small 5.5 |
| M555289000200 | Complex Spine System Hook, Pedicle, Large 5.5 |
| M555289000160 | Complex Spine System Hook, Laminar Small, Narrow Blade 5.5 |
| M555289000150 | Complex Spine System Hook, Laminar Small, Wide Blade 5.5 |
| M555289000140 | Complex Spine System Hook, Laminar Large, Wide Blade 5.5 |
| M555289000120 | Complex Spine System Hook, Laminar, Offset Left 5.5 |
| M555289000110 | Complex Spine System Hook, Laminar, Angled Down 5.5 |
| M555289000100 | Complex Spine System Hook, Laminar, Angled Up 5.5 |
| M555287509110 | 5.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 110mm |
| M555287509100 | 5.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 100mm |
| M555287509090 | 5.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 90mm |
| M555287509080 | 5.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 80mm |
| M555287509070 | 5.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 70mm |
| M555287509060 | 5.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 60mm |
| M555287509055 | 5.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 55mm |
| M555287509050 | 5.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 50mm |
| M555287509045 | 5.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 45mm |
| M555287509040 | 5.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 40mm |
| M555287509035 | 5.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 35mm |
| M555287509030 | 5.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 30mm |
| M555287501110 | ø7.5 x 110mm Reduction Polyaxial Screw Assembly |
| M555287501100 | ø7.5 x 100mm Reduction Polyaxial Screw Assembly |
| M555287501090 | ø7.5 x 90mm Reduction Polyaxial Screw Assembly |
| M555287501080 | ø7.5 x 80mm Reduction Polyaxial Screw Assembly |
| M555287501070 | ø7.5 x 70mm Reduction Polyaxial Screw Assembly |
| M555287501060 | ø7.5 x 60mm Reduction Polyaxial Screw Assembly |
| M555287501055 | ø7.5 x 55mm Reduction Polyaxial Screw Assembly |
| M555287501050 | ø7.5 x 50mm Reduction Polyaxial Screw Assembly |
| M555287501045 | ø7.5 x 45mm Reduction Polyaxial Screw Assembly |
| M555287501040 | ø7.5 x 40mm Reduction Polyaxial Screw Assembly |
| M555287501035 | ø7.5 x 35mm Reduction Polyaxial Screw Assembly |
| M555287501030 | ø7.5 x 30mm Reduction Polyaxial Screw Assembly |
| M555287501025 | ø7.5 x 25mm Reduction Polyaxial Screw Assembly |
| M555287500110 | ø7.5 x 110mm Polyaxial Screw Assembly |
| M555287500100 | ø7.5 x 100mm Polyaxial Screw Assembly |
| M555287500090 | ø7.5 x 90mm Polyaxial Screw Assembly |
| M555287500080 | ø7.5 x 80mm Polyaxial Screw Assembly |
| M555287500070 | ø7.5 x 70mm Polyaxial Screw Assembly |
| M555287500060 | ø7.5 x 60mm Polyaxial Screw Assembly |
| M555287500055 | ø7.5 x 55mm Polyaxial Screw Assembly |
| M555287500050 | ø7.5 x 50mm Polyaxial Screw Assembly |
| M555287500045 | ø7.5 x 45mm Polyaxial Screw Assembly |
| M555287500040 | ø7.5 x 40mm Polyaxial Screw Assembly |
| M555287500035 | ø7.5 x 35mm Polyaxial Screw Assembly |
| M555287500030 | ø7.5 x 30mm Polyaxial Screw Assembly |
| M555287500025 | ø7.5 x 25mm Polyaxial Screw Assembly |
| M555287252110 | ø7.2 Triple Lead Closed Polyaxial Screw Assembly, 110mm |