BIOSORB P822367234
GUDID 03760154002110
Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 50% porosity
S.B.M
Synthetic bone graft| Primary Device ID | 03760154002110 |
| NIH Device Record Key | 9a23f63b-3a55-41a9-8b38-6121945cb02c |
| Commercial Distribution Discontinuation | 2020-01-09 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | BIOSORB |
| Version Model Number | OTIS 50 |
| Catalog Number | P822367234 |
| Company DUNS | 772462123 |
| Company Name | S.B.M |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us |
Device Dimensions
| Height | 12 Millimeter |
| Height | 12 Millimeter |
| Height | 12 Millimeter |
| Height | 12 Millimeter |
| Height | 12 Millimeter |
| Height | 12 Millimeter |
| Height | 12 Millimeter |
| Height | 12 Millimeter |
| Height | 12 Millimeter |
| Height | 12 Millimeter |
| Height | 12 Millimeter |
| Height | 12 Millimeter |
| Height | 12 Millimeter |
| Height | 12 Millimeter |
| Height | 12 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03760154002110 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K071155
FDA Product Code
| MQV | Filler, Bone Void, Calcium Compound |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-10 |
| Device Publish Date | 2015-10-13 |
On-Brand Devices [BIOSORB]
| 03760154007009 | Absorbable calcium salt bone void filler |
| 03760154004831 | Absorbable calcium salt bone void filler |
| 03760154004824 | Absorbable calcium salt bone void filler |
| 03760154004688 | Absorbable calcium salt bone void filler |
| 03760154004671 | Absorbable calcium salt bone void filler |
| 03760154004640 | Absorbable calcium salt bone void filler |
| 03760154004633 | Absorbable calcium salt bone void filler |
| 03760154004282 | Absorbable calcium salt bone void filler |
| 03760154004275 | Absorbable calcium salt bone void filler |
| 03760154004237 | Absorbable calcium salt bone void filler |
| 03760154004220 | Absorbable calcium salt bone void filler |
| 03760154002141 | Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 50% porosity |
| 03760154002134 | Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 50% porosity |
| 03760154002110 | Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 50% porosity |
| 03760154002103 | Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 50% porosity |
| 03760154002097 | Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 50% porosity |
| 03760154002080 | Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 50% porosity |
| 03760154002073 | Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 50% porosity |
| 03760154002066 | Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 50% porosity |
| 03760154002059 | Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 50% porosity |
| 03760154001540 | Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity |
| 03760154001533 | Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity |
| 03760154001526 | Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity |
| 03760154001519 | Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity |
| 03760154001502 | Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity |
| 03760154001489 | Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity |
| 03760154001472 | Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity |
| 03760154000697 | Absorbable calcium salt bone void filler |
| 03760154000666 | Absorbable calcium salt bone void filler |
| 03760154000475 | Absorbable calcium salt bone void filler |
| 03760154000451 | Absorbable calcium salt bone void filler |
| 03760154000420 | Absorbable calcium salt bone void filler |
| 03760154000406 | Absorbable calcium salt bone void filler |
| 03760154000390 | Absorbable calcium salt bone void filler |
| 03760154000376 | Absorbable calcium salt bone void filler |
| 03760154000352 | Absorbable calcium salt bone void filler |
| 03760154000321 | Absorbable calcium salt bone void filler |
| 03760154000307 | Absorbable calcium salt bone void filler |
| 03760154000291 | Absorbable calcium salt bone void filler |
| 03760154000277 | Absorbable calcium salt bone void filler |
| 03760154000253 | Absorbable calcium salt bone void filler |
| 03760154000246 | Absorbable calcium salt bone void filler |
| 03760154000215 | Absorbable calcium salt bone void filler |
| 03760154000208 | Absorbable calcium salt bone void filler |
| 03760154000192 | Absorbable calcium salt bone void filler |
| 03760154000161 | Absorbable calcium salt bone void filler |
| 03760154000154 | Absorbable calcium salt bone void filler |
| 03760154000147 | Absorbable calcium salt bone void filler |
| 03760154000130 | Absorbable calcium salt bone void filler |
| 03760154000086 | Absorbable calcium salt bone void filler |
Trademark Results [BIOSORB]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOSORB 88832210 not registered Live/Pending |
Theragun, Inc. 2020-03-12 |
 BIOSORB 87338911 5649908 Live/Registered |
Trans America Product Technology, Inc. 2017-02-16 |
 BIOSORB 86801151 not registered Dead/Abandoned |
Novartis AG 2015-10-27 |
 BIOSORB 86217522 4617375 Live/Registered |
Baker Hughes Incorporated 2014-03-11 |
 BIOSORB 86081856 5114839 Live/Registered |
KCI USA, INC. 2013-10-03 |
 BIOSORB 79041464 not registered Dead/Abandoned |
HERNIAMESH S.R.L. 2007-05-30 |
 BIOSORB 78820726 not registered Dead/Abandoned |
ICON INTERVENTIONAL SYSTEMS, INC. 2006-02-22 |
 BIOSORB 78696644 3219521 Live/Registered |
Aquasol Corporation 2005-08-19 |
 BIOSORB 77947041 not registered Dead/Abandoned |
ICON Medical Corp. 2010-03-01 |
 BIOSORB 77482267 not registered Dead/Abandoned |
BioPharma Scientific, Inc. 2008-05-23 |
 BIOSORB 76291704 2802994 Dead/Cancelled |
Grain Processing Corporation 2001-07-30 |
 BIOSORB 76239878 not registered Dead/Abandoned |
Asian Sources Inc 2001-04-13 |
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