| Primary Device ID | 00810021380186 |
| NIH Device Record Key | 5805ffd8-fbab-4237-9506-ac0a32b633e0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GMA 2.0 Pedicle Screw System |
| Version Model Number | 601-7560-D |
| Catalog Number | 601-7560-D |
| Company DUNS | 063381119 |
| Company Name | GRAFTON MEDICAL ALLIANCE, 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 630-568-3061 |
| bsanchez@gmasurgical.com | |
| Phone | 630-568-3061 |
| bsanchez@gmasurgical.com | |
| Phone | 630-568-3061 |
| bsanchez@gmasurgical.com | |
| Phone | 630-568-3061 |
| bsanchez@gmasurgical.com | |
| Phone | 630-568-3061 |
| bsanchez@gmasurgical.com | |
| Phone | 630-568-3061 |
| bsanchez@gmasurgical.com | |
| Phone | 630-568-3061 |
| bsanchez@gmasurgical.com | |
| Phone | 630-568-3061 |
| bsanchez@gmasurgical.com | |
| Phone | 630-568-3061 |
| bsanchez@gmasurgical.com | |
| Phone | 630-568-3061 |
| bsanchez@gmasurgical.com | |
| Phone | 630-568-3061 |
| bsanchez@gmasurgical.com |
| Length | 60 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 60 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810021380186 [Primary] |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810021380186]
Moist Heat or Steam Sterilization
[00810021380186]
Moist Heat or Steam Sterilization
[00810021380186]
Moist Heat or Steam Sterilization
[00810021380186]
Moist Heat or Steam Sterilization
[00810021380186]
Moist Heat or Steam Sterilization
[00810021380186]
Moist Heat or Steam Sterilization
[00810021380186]
Moist Heat or Steam Sterilization
[00810021380186]
Moist Heat or Steam Sterilization
[00810021380186]
Moist Heat or Steam Sterilization
[00810021380186]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-01-17 |
| Device Publish Date | 2019-04-25 |
| 00810021380384 | PRE-BENT ROD, ø5.5 X 180 |
| 00810021380377 | PRE-BENT ROD, ø5.5 X 170 |
| 00810021380360 | PRE-BENT ROD, ø5.5 X 160 |
| 00810021380353 | PRE-BENT ROD, ø5.5 X 150 |
| 00810021380346 | PRE-BENT ROD, ø5.5 X 140 |
| 00810021380339 | PRE-BENT ROD, ø5.5 X 130 |
| 00810021380322 | PRE-BENT ROD, ø5.5 X 120 |
| 00810021380315 | PRE-BENT ROD, ø5.5 X 110 |
| 00810021380308 | PRE-BENT ROD, ø5.5 X 100 |
| 00810021380292 | PRE-BENT ROD, ø5.5 X 90 |
| 00810021380285 | PRE-BENT ROD, ø5.5 X 80 |
| 00810021380278 | PRE-BENT ROD, ø5.5 X 70 |
| 00810021380261 | PRE-BENT ROD, ø5.5 X 60 |
| 00810021380254 | PRE-BENT ROD, ø5.5 X 55 |
| 00810021380247 | PRE-BENT ROD, ø5.5 X 50 |
| 00810021380230 | PRE-BENT ROD, ø5.5 X 45 |
| 00810021380223 | PRE-BENT ROD, ø5.5 X 40 |
| 00810021380216 | PRE-BENT ROD, ø5.5 X 35 |
| 00810021380209 | PRE-BENT ROD, ø5.5 X 30 |
| 00810021380193 | LOCKING SCREW / SET SCREW |
| 00810021380186 | Polyaxial Pedicle Screw Assembly, 7.5 X 60, Dual Lead, Non-Cannulated |
| 00810021380179 | Polyaxial Pedicle Screw Assembly, 7.5 X 55, Dual Lead, Non-Cannulated |
| 00810021380162 | Polyaxial Pedicle Screw Assembly, 7.5 X 50, Dual Lead, Non-Cannulated |
| 00810021380155 | Polyaxial Pedicle Screw Assembly, 7.5 X 45, Dual Lead, Non-Cannulated |
| 00810021380148 | Polyaxial Pedicle Screw Assembly, 7.5 X 40, Dual Lead, Non-Cannulated |
| 00810021380131 | Polyaxial Pedicle Screw Assembly, 7.5 X 35, Dual Lead, Non-Cannulated |
| 00810021380124 | Polyaxial Pedicle Screw Assembly, 6.5 X 60, Dual Lead, Non-Cannulated |
| 00810021380117 | Polyaxial Pedicle Screw Assembly, 6.5 X 55, Dual Lead, Non-Cannulated |
| 00810021380100 | Polyaxial Pedicle Screw Assembly, 6.5 X 50, Dual Lead, Non-Cannulated |
| 00810021380094 | Polyaxial Pedicle Screw Assembly, 6.5 X 45, Dual Lead, Non-Cannulated |
| 00810021380087 | Polyaxial Pedicle Screw Assembly, 6.5 X 40, Dual Lead, Non-Cannulated |
| 00810021380070 | Polyaxial Pedicle Screw Assembly, 6.5 X 35, Dual Lead, Non-Cannulated |
| 00810021380063 | Polyaxial Pedicle Screw Assembly, 5.5 X 55, Dual Lead, Non-Cannulated |
| 00810021380056 | Polyaxial Pedicle Screw Assembly, 5.5 X 50, Dual Lead, Non-Cannulated |
| 00810021380049 | Polyaxial Pedicle Screw Assembly, 5.5 X 45, Dual Lead, Non-Cannulated |
| 00810021380032 | Polyaxial Pedicle Screw Assembly, 5.5 X 40, Dual Lead, Non-Cannulated |
| 00810021380025 | Polyaxial Pedicle Screw Assembly, 5.5 X 35, Dual Lead, Non-Cannulated |
| 00810021380018 | Polyaxial Pedicle Screw Assembly, 5.5 X 30, Dual Lead, Non-Cannulated |
| 00810021380469 | IMPLANT TRAY |
| 00810021380452 | INSTRUMENT TRAY #2 |
| 00810021380445 | INSTRUMENT TRAY #1 |
| 00810021380438 | GMA Pedicle Screw Driver Assembly |
| 00810021380421 | GMA Pedicle Screw Driver Assembly |