Mediant Anterior Cervical Plating System
Intelligent Implant Systems, LLC
INTELLIGENT IMPLANT SYSTEMS
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011121367 | 3011121367 | INTELLIGENT IMPLANT SYSTEMS | 1 | N | 2020-04-25 | 3300 Intl Airport Dr STE 1100 Charlotte NC US 28208 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 183314 | 1929145358 | K173935 | Mediant Anterior Cervical Plating System | KWQ | 2018-04-16 |
| 183314 | 1128846057 | K163056 | Revolution™ Spinal Fixation System | NKB | 2017-02-24 |
| 183314 | 2003091960 | K160216 | Revolution Spinal Fixation System | NKB | 2016-04-22 |
| 183314 | 1999112542 | K142939 | Revolution Spinal Fixation System | NKB | 2015-01-13 |
Product Codes Associated With Registrations#
PMN#
Revolution™ Spinal Fixation System
Intelligent Implant Systems, LLC
Revolution Spinal Fixation System
INTELLIGENT IMPLANT SYSTEMS, LLC
Revolution Spinal Fixation System
INTELLIGENT IMPLANT SYSTEMS, LLC
MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM
INTELLIGENT IMPLANT SYSTEMS, LLC
ACTIVE SCREW BONE SCREW
INTELLIGENT IMPLANT SYSTEMS, LLC
GUDID#
MEDIANT - Mediant Positioning Pins, Re-usable
2019-05-29
MEDIANT - Mediant 2.0 mm Drill Guide
2019-05-29
MEDIANT - Mediant 2.0 mm Drill
2019-05-29
Mediant Anterior Cervical Plate - Mediant 19 mm plate, 1-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 20 mm plate, 1-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 22 mm plate, 1-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 24 mm plate, 1-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 26 mm plate, 1-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 28 mm plate, 1-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 30 mm plate, 1-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 32 mm plate, 1-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 34 mm plate, 1-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 36 mm plate, 1-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 37 mm plate, 2-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 40 mm plate, 2-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 43 mm plate, 2-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 46 mm plate, 2-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 49 mm plate, 2-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 52 mm plate, 2-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 55 mm plate, 2-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 54 mm plate, 3-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 57 mm plate, 3-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 60 mm plate, 3-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 63 mm plate, 3-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 66 mm plate, 3-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 69 mm plate, 3-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 72 mm plate, 3-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 75 mm plate, 3-level
2018-05-17
Mediant Anterior Cervical Plate - Mediant 78 mm plate, 3-level
2018-05-17
Revolution - 25-30mm Straight Connector
2016-03-15
Revolution - 30-35mm Contoured Connector
2016-03-15
Revolution - 35-40mm Contoured Connector
2016-03-15
Revolution - 40-45mm Contoured Connector
2016-03-15
Revolution - 45-50mm Contoured Connector
2016-03-08
Revolution - 50-55mm Contoured Connector
2016-03-08
Revolution - 4.5 X 25mm Bone Screw, 4mm Offset
2016-03-14
Revolution - 4.5 X 30mm Bone Screw, 4mm Offset
2016-03-14
Revolution - 4.5 X 35mm Bone Screw, 4mm Offset
2016-03-14
Revolution - 4.5 X 40mm Bone Screw, 4mm Offset
2016-03-14
Revolution - 4.5 X 45mm Bone Screw, 4mm Offset
2016-03-14