FDA Registration
Active
🇺🇸 United States
BONE FOAM INC.
Reg #: 2321033
·
FEI: 3003399881
·
Expires 2026
Products
6
Proprietary Names
115
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- BONE FOAM INC.
- Registration Number
- 2321033
- FEI Number
- 3003399881
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2601 49th Ave N Ste 100
- City
- Minneapolis
- State
- MN
- ZIP
- 55430
- Country
- US
Owner / Operator
- Firm Name
- Bone Foam Inc.
- Operator Number
- 9046835
- Address
- 2601 49th Ave N, Suite 100
- City
- Minneapolis
- State
- MN
- Postal Code
- 55430
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Restraint, Protective | FMQ | Class 1 | General Hospital | No | 2026-05-21 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2001-07-06 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2021-04-28 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2024-03-27 |
| Component, Traction, Non-Invasive | KQZ | Class 1 | Orthopedic | No | 2020-06-04 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2021-04-28 |
Proprietary Names
104.ARS - H-Strap (Arm Restraint Strap) Box of 10
104.ARS-BX10 - H-Strap (Arm Restraint Strap) Box of 10
925.MBS - Tray Topper Small
104.NPS-TB - Nextend Torso Base
104.NPS-TA - Nextend Traction Anchor
925.UUELW - Wedge Universal Upper Extremity
925.LUEWL - Wedge Left Upper Extremity Large
925.PSCTR - Ramp Surgery Center Pediatric
925.ABD-BX10 - Axillary Bump, Disposable - Box of 10
925.JUB-BX5 - Jon Urology Bolsters (Pair) Box of 5
10-910-13-C-I - Troop 3-Set
925.HIPPY-BP - Hippy Base Package
925.5CB - Bump Cylindrical 5"
10-910-07-C - Troop Arm Board Pad Set of 2
925.HIPPY - Hippy
925.HIPPY-LEP - Hippy Lower Extremity Package
925.DR - Distal Radius Positioner
104.SLPS - Sideline
925.TRS - Ramp Shorty
925.ULT2-WS - Leg Tunnel Universal
925.PULT2-WS - Pediatric Leg Tunnel with Straps
925.TR - Ramp
925.UPS-S-UB - Universal Prone Upper Body Small
925.ABCUT - Axillary Bump Coated Multi-Use
10-911-06-C - Troop Elevation Pillow - Coated
104.NPL - Nextend Lite
925.KB - Knee Bolster
925.PTR - Ramp Pediatric
925.HIPPY-HB - Hippy Hip Bolster
925.EH - Limbo
925.PROP-R-BX5 - PROP- Disposable Regular Box of 5
925.UEBL - Block Upper Extremity Large
925.AAKWM - Wedge Acute Knee Medium
104.NPS - Nextend System
925.SCTR - Ramp Surgery Center
104.SLPS-HB - Hip Bolster
925.LUEWS - Wedge Left Upper Extremity Small
925.SG-BX10 - Shin Guard Box of 10
925.LW - Wedge Lateral
10-911-07-C - Troop Elevation Pillow Addition - Coated
104.NPLB - Nextend Lite Bolster
925.OAKWL - Wedge Obtuse Knee Large
10-910-02 - Troop Head Cradle - Disposable Box of 4
925.MBL - Tray Topper Large
925.9CB - Bump Cylindrical 9"
925.RLT2-WS - Leg Tunnel Right
925.PROPC-R - PROP - Coated Regular
925.MTO-C - Made to Order - Coated
925.LLT2-WS - Leg Tunnel Left
925.SHARK-S-WS - Shark Small
925.HIPPY-LB - Hippy Leg Board
104.SLPS-AB - Ax Bump
925.UPS-S-LB - Universal Prone Lower Body Small
925.KBEX-C - Knee Buddy Coated
925.HIPPY-TB - Hippy Torso Base
925.RUEWS - Wedge Right Upper Extremity Small
925.PROPC-L - PROP - Coated Large
925.LC - Leg Cradle
925.SER - Ramp Semi-Extended
925.SAS-WS-BX10 - Arm Guard Box of 10
925.AAKWL - Wedge Acute Knee Large
104.SLPS-TB - Sideline Torso Base
925.DLS-WS - Duall
925.HIPPY-PPBP-L - Hippy Padded Peg Board Post Large
104.LHS-BX10 - Head Guard Box of 10
10-910-12-C-I - Troop 2-Set
925.AAKWS - Wedge Acute Knee Small
104.NPS-SB - Nextend Scapula Bolster
925.MTO-D - Made to Order - Disposable
925.GULLY - Gully
10-910-02-C - Troop Head Cradle - Coated Box of 4
925.LLB-BX5 - Leg Guard Box of 5
925.UEBS - Block Upper Extremity Small
925.MBR - Tray Topper Regular
925.PC - Pelvic Cradle
925.OAKWS - Wedge Obtuse Knee Small
925.TRPP2 - Ramp Prone
925.LWS - Wedge Lateral Shorty
104.SLPS-LB - Sideline Lower Base
925.SHARK-WS - Shark Regular
925.UPS-R-UB - Universal Prone Upper Body Regular
104.NPSB - Nextend System Bolster
925.RUEWL - Wedge Right Upper Extremity Large
925.7CB - Bump Cylindrical 7"
925.HIPPY-PPBP-S - Hippy Padded Peg Board Post Small
925.UPS-R-LB - Universal Prone Lower Body Regular
925.PROP-L-BX5 - PROP - Disposable Large Box of 5
925.PF-SSP-BX6 - Prone One Box of 6
10-910-03 - Troop Disposable Barrier Cover Box of 20
925.HIPPY-DBC-BX20 - HIPPY Disposable Barrier Cover Box of 20
925.PC-DBC-BX20 - Pelvic Cradle Disposable Barrier Cover Box of 20
925.UPS-DBC-BX20 - Universal Prone Solution Disposable Barrier Cover Box of 20
104.SLPS-SUK-BX5 - Sideline Single Use Kit Box of 5
104.NPS-SUK-BX5 - Nextend Single Use Kit Box of 5
104.NPL-SUK-BX5 - Nextend Lite Single Use Kit Box of 5
925.REARLIEF - Rearlief Support Pillow
925.ZDK-MUSC-BX12 - Zero Degree Knee MUSC Box of 12
925.ZDK-AveraMcKennan-BX12 - Zero Degree Knee AveraMcKennan Box of 12
925.ERLE-Twin - Edema Reduction Leg Elevator Twin
925.ERLE-P-BX4 - Edema Reduction Leg Elevator Pediatric
925.ZDK-DOC-BX12 - Zero Degree Knee DOC Box of 12
925.ERLE-HC-BX3 - Leg Buddy Heel Cut Box of 3
925.ZDK-AveraMarshall-BX12 - Zero Degree Knee AveraMarshall Box of 12
925.ERLE-L-BX3 - Edema Reduction Leg Elevator Large - Box of 3
925.ERLE-R-BX3 - Leg Buddy Box of 3
925.ERLE-DELUXE - Edema Reduction Leg Elevator Deluxe
925.ZDKC - Zero Degree Knee Coated
925.ZDK-TDG-BX12 - Zero Degree Knee TDG Box of 12
925.ZDK-Mansfield-BX12 - Zero Degree Knee Mansfield Box of 12
925.ERLEC-L - Edema Reduction Leg Elevator Large - Coated
925.ZDK-BX12 - Zero Degree Knee Box of 12
925.ERLEC-R - Edema Reduction Leg Elevator Regular - Coated
737.RDLS - Restore Dual Leg Support
925.ERLE-Twin-DELUXE - Edema Reduction Leg Elevator Twin Deluxe
925.KBEX-BX4 - Knee Buddy Box of 4
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device