Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2321033

FEI Number

3003399881

Entity Name

BONE FOAM INC.

City/State/Country

Minneapolis, MN, US

Establishment Address

2601 49th Ave N Ste 100, Minneapolis, MN 55430, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Bone Foam Inc. (Owner Number: 9046835)

Owner / Operator Contact Address

2601 49th Ave N, Suite 100, Minneapolis, MN 55430, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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.NPS - Nextend System 104.SLPS-SUK-BX5 - Sideline Single Use Kit Box of 5 104.NPL - Nextend Lite 104.NPS-SUK-BX5 - Nextend Single Use Kit Box of 5 104.SLPS - Sideline 104.NPL-SUK-BX5 - Nextend Lite Single Use Kit Box of 5

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2026-05-21
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2001-07-06
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2021-04-28
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2024-03-27
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2020-06-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bone Foam Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962327	Sekure Seat Corp.	SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE	1997-03-06
K963243	Heelbo, Inc.	HEELBO BLAZER SLEEVED JACKET	1996-10-01

Similar Registrations

Registration Number	Establishment Name	Location
9681527	PINEL MEDICAL, INC.	KITCHENER Ontario, CA
3010865220	YANGZHOU CHANGQINGSHU SPORTS GOODS CO., LTD	Jiangdu, Yangzhou Jiangsu, CN
3021135929	COZEECOO, LLC	Princeton, NJ, US
3027592416	VIPER EMERGENCY MEDICAL RESTRAINTS, LLC	Shrewsbury, MA, US
3015173212	Medline Industries, LP - Mexicali (MXC)	Mexicali Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2321033. Last updated year: 2026. Please use registration number 2321033 when referencing this establishment in official correspondence.