FDA Registration
Active
🇺🇸 United States
104.SLPS - Lateral Lumbar Positioning System
Reg #: 2321033
·
FEI: 3003399881
·
Expires 2025
Products
1
Proprietary Names
91
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- BONE FOAM INC.
- Registration Number
- 2321033
- FEI Number
- 3003399881
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 20175 County Road 50
- City
- Corcoran
- State
- MN
- ZIP
- 55340
- Country
- US
Owner / Operator
- Firm Name
- Bone Foam Inc.
- Operator Number
- 9046835
- Address
- 20175 County Rd 50
- City
- Corcoran
- State
- MN
- Postal Code
- 55340
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2001-07-06 |
Proprietary Names
104.SLPS - Lateral Lumbar Positioning System
104.NPS-TB - Anterior Cervical Positioning System Torso Base
925.TRPP2 - The Ramp Prone Positioner 2
925.OAKWL - Obtuse Angle Knee Wedge Large
925.UPS-R - Universal Prone Solution - Regular (with Disposable Barrier Covers)
925.ABD-BX10 - Axillary Bump Disposable - Box of 10
925.UEBS - Upper Extremity Block Small
925.PSCTR - Surgery Center Pediatric Ramp
925.LC - Leg Cradle
925.PROP-L-BX5 - Pelvic Raising Operative Positioner Disposable - Box of 5
925.7CB - 7 Cylindrical Bump
10-910-12-C-I - Troop Elevation Pillow - Coated (2-set)
925.AAKWL - Acute Angle Knee Wedge Large
104.NPS-TA - Anterior Cervical Positioning System Traction Anchor
925.HIPPY-HB - Direct Anterior Hip Positioning System Hip Bolster
925.AAKWS - Acute Angle Knee Wedge Small
104.SLPS-LB - Lateral Lumbar Positioning System Lower Base
10-910-02 - Head Cradle - Disposable - Box of 4
925.SCTR - Surgery Center Ramp (Leg Elevator)
925.SER - Semi-Extended Ramp
925.DLS-WS - Dual Leg Support with Strap
925.UPS-R-UB - Universal Prone Solution - Regular Upper Body
925.MBS - Tray Topper Small (Fits Small Mayo Stand 12 5/8" x 19 1/8")
925.UUELW - Universal Upper Extremity Lateral Wedge
925.UPS-R-LB - Universal Prone Solution - Regular Lower Body
925.PROPC-R - Pelvic Raising Operative Positioner Coated Regular
925.MBL - Tray Topper Small (Fits Small Mayo Stand 12 5/8" x 19 1/8")
925.PTR - Pediatric Ramp (Leg Elevator)
104.NPS-SB - Anterior Cervical Positioning System Scapula Bolster
925.LWS - Lateral Wedge Shorty
925.UPS-L - Universal Prone Solution - Large
10-910-02-C - Head Cradle - Coated - Box of 4
925.MBL - Tray Topper Large (Fits Large Mayo Stand 20 x 25)
925.HIPPY - Direct Anterior Hip Positioning System
925.ULT2-WS - Universal Leg Tunnel with Straps
925.MTO-D - Made To Order - Disposable Positioner
925.LLB-BX5 - Lateral Leg Bolster - Box of 5
925.UPS-S-UB - Universal Prone Solution - Small Upper Body
925.UPS-S - Universal Prone Solution - Small
925.DR - Distal Radius Positioner
925.RLT2-WS - Right Leg Tunnel with Straps
10-910-13-C-I - Troop Elevation Pillow - Coated (3-set)
104.SLPS-HB - Lateral Lumbar Positioning System Hip Bolster
925.PROP-R-BX5 - Pelvic Raising Operative Positioner Disposable - Box of 5
925.TR - The Ramp (Leg Elevator)
925.UPS-S-LB - Universal Prone Solution - Small Lower Body
925.UEBL - Upper Extremity Block Large
925.LUEWS - Left Upper Extremity Wedge Small
925.PROPC-L - Pelvic Raising Operative Positioner Coated Large
925.PULT2-WS - Pediatric Leg Tunnel with Straps
925.HIPPY-LEP - Direct Anterior Hip Positioning System Lower Extremity Package
925.MBR - Tray Topper Regular (Fits Standard Mayo Stand 16 1/4x 21 1/4)
104.NPS - Anterior Cervical Positioning System
104.LHS-BX10 - Head Guard - Box of 10
925.SG-BX10 - Shin Guard - Box of 10
925.MTO-C - Made To Order - Reusable Positioner
925.SHARK-WS - The Shark with Straps
925.UPS-R - Universal Prone Solution - Regular
925.HIPPY-LB - Direct Anterior Hip Positioning System Leg Board
925.OAKWS - Obtuse Angle Knee Wedge Small
925.EH - Extremity Holder
925.HIPPY-TB - Direct Anterior Hip Positioning System Torso Base
104.SLPS-AB - Lateral Lumbar Positioning System Axillary Bolster
925.JUB-BX5 - Jon Urology Bolsters (Pair of Bolsters) - Box of 5 pairs
925.KB - Knee Bolster
925.RUEWS - Right Upper Extremity Wedge Small
10-910-07-C - Arm Board Pad - Coated - Set of 2
925.LUEWL - Left Upper Extremity Wedge Large
925.RUEWL - Right Upper Extremity Wedge Large
925.SHARK-S-WS - The Shark Small with Straps
925.LW - Lateral Wedge
925.LLT2-WS - Left Leg Tunnel with Straps
10-910-00 - Troop Elevation Pillow (Foam) - Disposable (with Barrier Cover & Head Cradle) Box of 3
925.KBEX-C - Knee Buddy Coated
10-911-06-C - Troop Elevation Pillow - Coated
925.9CB - 9 Cylindrical Bump
925.HIPPY-PPBP-L - Direct Anterior Hip Positioning System Padded Peg Board Post Large
925.HIPPY-BP - Direct Anterior Hip Positioning System Base Package
925.AAKWM - Acute Angle Knee Wedge Medium
925.ABCUT - Axillary Bump Coated Multi-Use
10-910-06-C - Troop Elevation Pillow - Complete System
104.SLPS-TB - Lateral Lumbar Positioning System Torso Base
10-910-01-C - Troop Elevation Pillow - Standard System
925.5CB - 5 Cylindrical Bump
925.GULLY - The Gully Pad
925.TRS - The Ramp Shorty (Leg Elevator)
925.SAS-WS-BX10 - Single Arm Support - Box of 10
925.HIPPY-PPBP-S - Direct Anterior Hip Positioning System Padded Peg Board Post Small
10-911-07-C - Troop Elevation Pillow Addition - Coated
925.UPS-S - Universal Prone Solution - Small (with Disposable Barrier Covers)
925.PC - Pelvic Cradle
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198