FDA Registration
Active
🇺🇸 United States
New Style Double Ball Joint Head Section
Reg #: 1825014
·
FEI: 1825014
·
Expires 2025
Products
1
Proprietary Names
119
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Skytron, LLC
- Registration Number
- 1825014
- FEI Number
- 1825014
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5085 Corporate Exchange Blvd SE
- City
- Grand Rapids
- State
- MI
- ZIP
- 49512
- Country
- US
Owner / Operator
- Firm Name
- Skytron, LLC
- Operator Number
- 9918015
- Address
- 5085 Corporate Exchange Blvd SE, --
- City
- Grand Rapids
- State
- MI
- Postal Code
- 49512
- Country
- US
- Correspondent
- Robert - Vreeland
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Table, Operating-Room, Ac-Powered | FQO | Class 1 | General, Plastic Surgery | No | 2015-04-22 |
Proprietary Names
New Style Double Ball Joint Head Section
3-060-08 5 Side Extension
Ergon Series Skybooms; Freedom Series Skybooms; Various Models of Skybooms
Head end uro tray adapter for rectangular type metal tray (adapter only)
1602 X-ray top set
"L" type anesthesia screen with two adjustable wings, without clamp
Pediatric Extension
Standard Armboard
Urology bracket set
Levitator accessory cart kit for use with 6-020-10
Instrument tray
OB Hand grips (pr)
Neuro adapter
Carbon Fiber Armboard for 3000 and 3003 (slide under pad type)
Foot rests (pr)
Silhouetted narrow head section (6002, 1700, 3600B & 6700 series) no side rails, includes a 2" pad
Premium Armboard
5 piece split leg accessory cart kit for use with 6-020-10
Side Rail extension and clamp assembly (7")
Universal split leg accessory w/2" pad
2" restraint strap (65" two pieces 42"/23")(1 buckle)
Organizer, wall mount
Uro drain tray with mounting brackets (3600B)
Catheter extension
Knee/calf ankl-lock crutches with pads and without clamps
Uro drain tray with mounting brackets (3100A)
Radiographic top (6700 series)
Softee strap
Tri-clamp - round or flat bar
Foot control - 3 function (3003) (Trend, tilt, elev)
EZ grip bar clamp for HD levitators
Foot Control 3502/6302
Shoulder support (pr)
Heavy duty support rod for round bar clamp
Angle block adapter for pendant controls
Radiographic top for KUB board
EZ-Roll cart
Radiolucent standard armboard (without pad)
Lower back section - 6700 series/3600B (for use with split leg accessory 4-030-61)
Ankl-lock III lithotomy stirrups without clamps, with pads and straps
Schure Socket XL
Auxiliary base connector kit (3000)
Straps for 4-020-02-4 (pr)
Head end uro tray adapter with uro drain tray crescent type (1700, 6002 & 6700 series)
Radiographic top (3600B)
Anesthesia screen "L" type without clamp
Premium locking armboard
Basket accessory cart kit for use with 6-020-10
Clamp on rail
Raised Armboard without clamp
Cart, Ortho Trax
40" Carbon fiber extension for 3600B & 6700 series
47.5" Nissen strap set
40" carbon fiber accessory kit for use with 6-020-10
Pivoting Carbon fiber clamp-on armboard for 3000 & 3003 (36" & 48" extensions)
Lithotomy stirrups (pr) without clamps
Narrow head section (6002, 1700, 3600B & 6700 series)
KUB Board
Shoulder chair accessory cart kit for use with 6-020-10
Universal side rail clamp II
Beach chair head rest upgrade dual ball joint
Flexfit 600 stirrups
Auxiliary base connector kit (3003)
Transfer board pin type (3600B & 6700 series)
75" patient safety strap (two piece 37"/38")
Transfer board, pin type (6002, 1700, 6700 series & 3600B)
58.5" snap restraint strap
Transfer board, side rail type (3100A, 6002, 1700, 6700 series & 3600B)
105" restraint strap (2 buckles)
Head end uro tray adapter for crescent type uro metal tray (adapter only)
Radiographic top (3501C)
Anesthesia screen, "wing" type with clamps
Foot Control 3602/6702
Adapter to attach 3-040-20 to leg pins
Standard bar clamp
Angle block installation
Nylon restraint belt with velcro
Bar clamp (use with chest and waist supports only)
Lateral brace for shoulder positioners
18" foot extension with built in clamps and hd support rod
96" restraint strap (2 buckles)
Chest and waist support (pr)
18" knee rest
Radiographic top (6300)
Foot control - 3 function (6700 series) (Trend, tilt, elev)
Multi-task armboard w/pad (requires clamp) (Sure Clamp 6-040-11 recommended)
General purpose head support
Prone positioning frame (cloward saddle)
Uro drain tray with mounting brackets (6002 & 6700 series)
Radiographic top (1700)
Ortho Trax System
Heavy duty support rod for flat bar clamp
Skytron Urology Bracket
10" foot extension without pad
96" restraint strap (velcro fastener)
Skytron beach chair
Heavy duty levitator stirrups, blade type, without clamps, with pads and straps
Auxiliary base connector installation
12" Carbon fiber arm surgery board for 3000 & 3003 (36" & 48" extensions)
E-Z Lift assist beach chair
Levitator stirrups, blade type, without clamps, with pads and straps
Auxiliary base connector kit (1700)
Table side extension (3-1/2" x 15" with side rails
Split leg section for 6700 series & 3600B
Springloc clamp
Auxiliary base connector kit (3501B)
Patient security straps with velcro
Organizer, stirrup kit
G-Series Clamp
G-Series Pediatric Extension
Versa Fit Bariatric Boot (sold as a pair)
Versa Fit Elite Boot (sold as a pair)
G-Series KUB
G-Series Light Weight Leg Section
Flex Fit 2
G-Series 44" Carbon Fiber Extension
Versa Fit
Versa Fit Standard Boot (sold as a pair)
Skytron Lat Brace "New Style" Red
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility