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
Support, Patient Position CCX

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 1/4”x 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