| Primary Device ID | M696SP200140 |
| NIH Device Record Key | 961484cf-77f3-4b53-a841-6498500ed4eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OIC Pedicle Screw System |
| Version Model Number | SP20014 |
| Company DUNS | 070061160 |
| Company Name | ORTHOPAEDIC IMPLANT COMPANY, THE |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M696SP200140 [Primary] |
| MNI | Orthosis, Spinal Pedicle Fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
[M696SP200140]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-12-08 |
| Device Publish Date | 2017-02-01 |
| M69623020410 | STERILIZATION CASE PEDICLE SCREW CASE 2 |
| M69623010410 | STERILIZATION CASE PEDICLE SCREW CASE |
| M69633710200 | BONE AWL |
| M6962261020R0 | IN SITU RIGHT |
| M6962261010L0 | IN SITU LEFT |
| M69622310200 | ROD BENDER |
| M69622111200 | DISTRACTOR |
| M69622011200 | COMPRESSOR |
| M696SP200160 | 7.5MM BONE TAP |
| M696SP200150 | 6.5MM BONE TAP |
| M696SP200140 | 5.5MM BONE TAP |
| M696SR55800 | STRAIGHT ROD, 80MM |
| M696SR55700 | STRAIGHT ROD, 70MM |
| M696SR55500 | STRAIGHT ROD, 50MM |
| M696SR55400 | STRAIGHT ROD, 40MM |
| M696SR552000 | STRAIGHT ROD, 200MM |
| M696SR551800 | STRAIGHT ROD, 180MM |
| M696SR551500 | STRAIGHT ROD, 150MM |
| M696SR551200 | STRAIGHT ROD, 120MM |
| M696SR551100 | STRAIGHT ROD, 110MM |
| M696SR551000 | STRAIGHT ROD, 100MM |
| M696SP5555550 | PEDICLE SCREW, POLYAXIAL, 5.5MM X 55MM |
| M696SP200210 | SHEATH, IMPLANT DRIVER |
| M696SP200120 | SET SCREW GUIDE |
| M696SP200070 | CONNECTOR HEX DRIVER |
| M696SP200060 | CONNECTOR SCREW DRIVER |
| M696SP200050 | HEAD TILTING WRENCH |
| M696SP200040 | IMPLANT DRIVER |
| M696SP200030 | SET SCREW DRIVER |
| M696SP200020 | ROD PERSUADER |
| M696SP200010 | SET SCREW INSTALLATION DRIVER |
| M696SP200000 | ANTI TORQUE WRENCH |
| M696PS5575550 | PEDICLE SCREW, POLYAXIAL, 7.5MM X 55MM |
| M696PS5575500 | PEDICLE SCREW, POLYAXIAL, 7.5MM X 50MM |
| M696PS5575450 | PEDICLE SCREW, POLYAXIAL, 7.5MM X 45MM |
| M696PS5575400 | PEDICLE SCREW, POLYAXIAL, 7.5MM X 40MM |
| M696PS5575350 | PEDICLE SCREW, POLYAXIAL, 7.5MM X 35MM |
| M696PS5575300 | PEDICLE SCREW, POLYAXIAL, 7.5MM X 30MM |
| M696PS5565550 | PEDICLE SCREW, POLYAXIAL, 6.5MM X 55MM |
| M696PS5565500 | PEDICLE SCREW, POLYAXIAL, 6.5MM X 50MM |
| M696PS5565450 | PEDICLE SCREW, POLYAXIAL, 6.5MM X 45MM |
| M696PS5565400 | PEDICLE SCREW, POLYAXIAL, 6.5MM X 40MM |
| M696PS5565350 | PEDICLE SCREW, POLYAXIAL, 6.5MM X 35MM |
| M696PS5565300 | PEDICLE SCREW, POLYAXIAL, 6.5MM X 30MM |
| M696PS5555550 | PEDICLE SCREW, POLYAXIAL, 5.5MM X 55MM |
| M696PS5555500 | PEDICLE SCREW, POLYAXIAL, 5.5MM X 50MM |
| M696PS5555450 | PEDICLE SCREW, POLYAXIAL, 5.5MM X 45MM |
| M696PS5555400 | PEDICLE SCREW, POLYAXIAL, 5.5MM X 40MM |
| M696PS5555350 | PEDICLE SCREW, POLYAXIAL, 5.5MM X 35MM |
| M696PS5555300 | PEDICLE SCREW, POLYAXIAL, 5.5MM X 30MM |