| Primary Device ID | M69601FIB010 |
| NIH Device Record Key | d74a034a-5bed-4292-ba62-6859248479a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OIC Variable Angle Small Fragment Locking Plate System |
| Version Model Number | 01-FIB01 |
| 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 | M69601FIB010 [Primary] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
[M69601FIB010]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2021-07-08 |
| Device Publish Date | 2017-02-09 |
| M69601SF020 | SHARP HOOK |
| 10811998033386 | SHARP HOOK |
| M696LG00280 | DRILL GUIDE 2.8MM THREADED |
| M696LG00180 | DRILL GUIDE 1.8MM THREADED |
| M696DG28350 | DRILL GUIDE 2.8/3.5MM |
| M696DG28280 | DRILL GUIDE 2.8MM BONE/PLATE |
| M696DG18180 | DRILL GUIDE 1.8MM FIX/VARIABLE ANGLE |
| 10811998034154 | DRILL GUIDE 2.8MM THREADED |
| 10811998034147 | DRILL GUIDE 1.8MM THREADED |
| 10811998033997 | DRILL GUIDE 2.8/3.5MM |
| 10811998033980 | DRILL GUIDE 2.8MM BONE/PLATE |
| 10811998033973 | DRILL GUIDE 1.8MM FIX/VARIABLE ANGLE |
| M69601SF130 | SCREW FORCEPS SMALL FRAGMENT |
| 10811998033492 | SCREW FORCEPS SMALL FRAGMENT |
| 10811998035533 | 1.6MM X 85MM PROVISIONAL WIRE (5 PACK) |
| 10811998039487 | SMALL FRAG 2 STERILIZATION CASE |
| 10811998035571 | 3.5MM X 8MM CORTEX SCREW |
| 10811998035564 | 3.5MM X 8MM LOCKING SCREW |
| 10811998035557 | 2.5MM X 8MM CORTEX SCREW |
| 10811998035540 | 2.5MM X 8MM LOCKING SCREW |
| 10811998035526 | 2.8MM DRILL TOP HAT |
| 10811998035519 | 0.8NM TORQUE LIMITER |
| 10811998035502 | 1.5NM TORQUE LIMITER |
| 10811998035496 | SMALL FRAGMENT MEDIUM DEPTH GAUGE |
| 10811998035489 | UNIVERSAL PLATE BENDER |
| 10811998035472 | THICK TIPPED BONE HOLDERS |
| 10811998035465 | 2.5MM X 110MM DRILL BIT |
| 10811998035458 | 1.8/2.5MM DRILL GUIDE |
| 10811998035441 | 1.8MM DRILL TOP HAT |
| 10811998035434 | 10 HOLE RIGHT DISTAL CLAVICLE PLATE |
| 10811998035427 | 10 HOLE LEFT DISTAL CLAVICLE PLATE |
| 10811998035410 | 8 HOLE RIGHT DISTAL CLAVICLE PLATE |
| 10811998035403 | 8 HOLE LEFT DISTAL CLAVICLE PLATE |
| M696DR0010 | STERILIZATION CASE DRILL BIT CADDY |
| M69601SF000 | STERILIZATION CASE VA SMALL FRAG BASE |
| M69601PRXTIB010 | STERILIZATION CASE PROX TIB PLATES |
| M69601PHP040 | STERILIZATION CASE PROXIMAL PLATE COMPLETE |
| M69601PHP030 | STERILIZATION CASE PROXIMAL HUMERUS PLATES INNER |
| M69601FIB010 | STERILIZATION CASE FIBULA PLATES |
| M69601DRP040 | STERILIZATION CASE DISTAL RADIUS PLATES COMPLETE |
| M69601DRP030 | STERILIZATION CASE DISTAL RADIUS PLATES INNER |
| M69601CP020 | STERILIZATION CASE CLAVICLE PLATES COMPLETE |
| M69601CP010 | STERILIZATION CASE CLAVICLE PLATES INNER |
| M69601ANK010 | STERILIZATION CASE ANKLE PLATES |
| M696014150 | STERILIZATION CASE UNIVERSAL OUTER MINI |
| 10811998033362 | STERILIZATION CASE VA SMALL FRAG BASE |
| 10811998033355 | STERILIZATION CASE PROX TIB PLATES |
| 10811998033348 | STERILIZATION CASE PROXIMAL PLATE COMPLETE |
| 10811998033317 | STERILIZATION CASE DISTAL RADIUS PLATES COMPLETE |
| 10811998033263 | STERILIZATION CASE CLAVICLE PLATES COMPLETE |