Cervical Plate
510(k) K113170
Cervical Plate is a medical device (FDA Class II; FDA product code KWQ, Appliance, Fixation, Spinal Intervertebral Body) made by Eisertech, LLC, cleared under FDA 510(k) K113170 on 6 Apr 2012, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK113170 | Date6 Apr 2012 | StatusActive |
Official records
- FDA 510(k) database K113170
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KWQ
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3060
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K113170
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Cervical Plate 100057-0 | 100057-0 / 100057-0 | B5231000570 | On the market | |
| Cervical Plate 100065-0 | 100065-0 / 100065-0 | B5231000650 | On the market | |
| Cervical Plate 100075-0 | 100075-0 / 100075-0 | B5231000750 | On the market | |
| Cervical Plate 100078-0 | 100078-0 / 100078-0 | B5231000780 | On the market | |
| Cervical Plate 100079-3012 | 100079-3012 / 100079-3012 | B5231000793012 | On the market | |
| Cervical Plate 100079-3014 | 100079-3014 / 100079-3014 | B5231000793014 | On the market | |
| Cervical Plate 100087-24 | 100087-24 / 100087-24 | B52310008724 | On the market | |
| Cervical Plate 100087-26 | 100087-26 / 100087-26 | B52310008726 | On the market | |
| Cervical Plate 100087-28 | 100087-28 / 100087-28 | B52310008728 | On the market | |
| Cervical Plate 100087-30 | 100087-30 / 100087-30 | B52310008730 | On the market | |
| Cervical Plate 100087-32 | 100087-32 / 100087-32 | B52310008732 | On the market | |
| Cervical Plate 100087-34 | 100087-34 / 100087-34 | B52310008734 | On the market | |
| Cervical Plate 100087-36 | 100087-36 / 100087-36 | B52310008736 | On the market | |
| Cervical Plate 100088-38 | 100088-38 / 100088-38 | B52310008838 | On the market | |
| Cervical Plate 100088-40 | 100088-40 / 100088-40 | B52310008840 | On the market | |
| Cervical Plate 100088-44 | 100088-44 / 100088-44 | B52310008844 | On the market | |
| Cervical Plate 100088-46 | 100088-46 / 100088-46 | B52310008846 | On the market | |
| Cervical Plate 100088-48 | 100088-48 / 100088-48 | B52310008848 | On the market | |
| Cervical Plate 100088-50 | 100088-50 / 100088-50 | B52310008850 | On the market | |
| Cervical Plate 100088-52 | 100088-52 / 100088-52 | B52310008852 | On the market | |
| Cervical Plate 100089-54 | 100089-54 / 100089-54 | B52310008954 | On the market | |
| Cervical Plate 100089-57 | 100089-57 / 100089-57 | B52310008957 | On the market | |
| Cervical Plate 100089-60 | 100089-60 / 100089-60 | B52310008960 | On the market | |
| Cervical Plate 100089-69 | 100089-69 / 100089-69 | B52310008969 | On the market | |
| Cervical Plate 100089-72 | 100089-72 / 100089-72 | B52310008972 | On the market | |
| Cervical Plate 100089-75 | 100089-75 / 100089-75 | B52310008975 | On the market | |
| Cervical Plate 100089-78 | 100089-78 / 100089-78 | B52310008978 | On the market | |
| Cervical Plate 100090-102 | 100090-102 / 100090-102 | B523100090102 | On the market | |
| Cervical Plate 100090-106 | 100090-106 / 100090-106 | B523100090106 | On the market | |
| Cervical Plate 100090-70 | 100090-70 / 100090-70 | B52310009070 | On the market | |
| Cervical Plate 100090-74 | 100090-74 / 100090-74 | B52310009074 | On the market | |
| Cervical Plate 100090-78 | 100090-78 / 100090-78 | B52310009078 | On the market | |
| Cervical Plate 100090-82 | 100090-82 / 100090-82 | B52310009082 | On the market | |
| Cervical Plate 100090-86 | 100090-86 / 100090-86 | B52310009086 | On the market | |
| Cervical Plate 100090-90 | 100090-90 / 100090-90 | B52310009090 | On the market | |
| Cervical Plate 100090-94 | 100090-94 / 100090-94 | B52310009094 | On the market | |
| Cervical Plate 100090-98 | 100090-98 / 100090-98 | B52310009098 | On the market | |
| Cervical Plate 100093-4010 | 100093-4010 / 100093-4010 | B5231000934010 | On the market | |
| Cervical Plate 100093-4012 | 100093-4012 / 100093-4012 | B5231000934012 | On the market | |
| Cervical Plate 100093-4014 | 100093-4014 / 100093-4014 | B5231000934014 | On the market | |
| Cervical Plate 100093-4510 | 100093-4510 / 100093-4510 | B5231000934510 | On the market | |
| Cervical Plate 100093-4514 | 100093-4514 / 100093-4514 | B5231000934514 | On the market | |
| Cervical Plate 100093-4516 | 100093-4516 / 100093-4516 | B5231000934516 | On the market | |
| Cervical Plate 100094-4010 | 100094-4010 / 100094-4010 | B5231000944010 | On the market | |
| Cervical Plate 100094-4012 | 100094-4012 / 100094-4012 | B5231000944012 | On the market | |
| Cervical Plate 100094-4014 | 100094-4014 / 100094-4014 | B5231000944014 | On the market | |
| Cervical Plate 100094-4016 | 100094-4016 / 100094-4016 | B5231000944016 | On the market | |
| Cervical Plate 100094-4510 | 100094-4510 / 100094-4510 | B5231000944510 | On the market | |
| Cervical Plate 100094-4516 | 100094-4516 / 100094-4516 | B5231000944516 | On the market | |
| Cervical Plate 100163-0 | 100163-0 / 100163-0 | B5231001630 | On the market |
Similar devices
Other devices filed under FDA product code KWQ (Appliance, Fixation, Spinal Intervertebral Body).
- 4CIS® Pinehurst Anterior Cervical Plate system by SOLCO BIOMEDICAL CORP.
- Palisades™ Buttress Plate System by Bethesda Medical Devices
- HYBRID ANTERIOR CERVICAL PLATE SYSTEM by Depuy Spine, Inc.
- ARCHON ANTERIOR CERVICAL PLATE SYSTE, by Nu Vasive, Incorporated
- VENTURE ANTERIOR CERVICAL PLATING SYSTEM by MEDTRONIC SOFAMOR DANEK, INC.
- SPIDER CERVICAL PLATING (SCP) SYSTEM by X-Spine Systems, Inc.
- PYRAMID ANTERIOR PLATE FIXATION SYSTEM by MEDTRONIC SOFAMOR DANEK, INC.
- EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM by Depuy Spine, Inc.
- SIMMONS PLATING SYSTEM by Smith & Nephew Richards, Inc.
- D.T.T. LOCK SCREW INSERTER by Depuy, Inc.