Vitoss 2102-1410
GUDID 00808232000443
Bone Graft Substitute, Foam Pack, Beta-Tricalcium Phosphate and Type I Bovine Collagen
Stryker Corporation
Bone matrix implant, composite| Primary Device ID | 00808232000443 |
| NIH Device Record Key | a78495ee-a5ed-4b8d-ad0c-de74347261b9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vitoss |
| Version Model Number | 2102-1410 |
| Catalog Number | 2102-1410 |
| Company DUNS | 149183167 |
| Company Name | Stryker Corporation |
| 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 | false |
| 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 | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com | |
| Phone | +1(610)640-1775 |
| spacustserv@stryker.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00808232000443 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K032288
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 | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [Vitoss]
| 00808232000443 | Bone Graft Substitute, Foam Pack, Beta-Tricalcium Phosphate and Type I Bovine Collagen |
| 00808232000436 | Bone Graft Substitute, Foam Pack, Beta-Tricalcium Phosphate and Type I Bovine Collagen |
| 00808232000429 | Bone Graft Substitute, Foam Pack, Beta-Tricalcium Phosphate and Type I Bovine Collagen |
| 00808232000412 | Bone Graft Substitute, Foam Pack, Beta-Tricalcium Phosphate and Type I Bovine Collagen |
| 00808232000382 | Bone Graft Substitute, Foam Flow, Beta-Tricalcium Phosphate and Type I Bovine Collagen |
| 00808232000375 | Bone Graft Substitute, Foam Flow, Beta-Tricalcium Phosphate and Type I Bovine Collagen |
| 00808232000313 | Bone Graft Substitute, Foam Strip, Beta-Tricalcium Phosphate and Type I Bovine Collagen |
| 00808232000306 | Bone Graft Substitute, Foam Strip, Beta-Tricalcium Phosphate and Type I Bovine Collagen |
| 00808232000290 | Bone Graft Substitute, Foam Strip, Beta-Tricalcium Phosphate and Type I Bovine Collagen |
| 00808232000276 | Bone Graft Substitute, Foam Strip, Beta-Tricalcium Phosphate and Type I Bovine Collagen |
| 00808232000269 | Bone Graft Substitute, Foam Strip, Beta-Tricalcium Phosphate and Type I Bovine Collagen |
| 00808232000245 | Bone Graft Substitute, Foam Cup, Beta-Tricalcium Phosphate and Type I Bovine Collagen |
| 00808232000207 | Bone Graft Substitute, 4-7mm Macro-Morsels, Beta-Tricalcium Phosphate |
| 00808232000191 | Bone Graft Substitute, 4-7mm Macro-Morsels, Beta-Tricalcium Phosphate |
| 00808232000153 | Bone Graft Substitute, 1-2mm Micro-Morsels, Beta-Tricalcium Phosphate |
| 00808232000146 | Bone Graft Substitute, 1-4mm Morsels, Beta-Tricalcium Phosphate |
| 00808232000139 | Bone Graft Substitute, 1-4mm Morsels, Beta-Tricalcium Phosphate |
| 00808232000122 | Bone Graft Substitute, 1-4mm Morsels, Beta-Tricalcium Phosphate |
| 00808232000115 | Bone Graft Substitute, 1-4mm Morsels, Beta-Tricalcium Phosphate |
| 00808232000108 | Bone Graft Substitute, 1-4mm Morsels Filled Canister, Beta-Tricalcium Phosphate |
| 00808232000092 | Bone Graft Substitute, 1-4mm Morsels Filled Canister, Beta-Tricalcium Phosphate |
| 00808232000085 | Bone Graft Substitute, 1-4mm Morsels Filled Canister, Beta-Tricalcium Phosphate |
| 00808232000078 | Bone Graft Substitute, 1-4mm Morsels Filled Canister, Beta-Tricalcium Phosphate |
| 00808232000061 | Bone Graft Substitute, 1-2mm Micro-Morsels Filled Canister, Beta-Tricalcium Phosphate |
| 00808232000054 | Bone Graft Substitute, 1-2mm Micro-Morsels Filled Canister, Beta-Tricalcium Phosphate |
| 00808232000047 | Bone Graft Substitute, 1-2mm Micro-Morsels Filled Canister, Beta-Tricalcium Phosphate |
| 00808232000030 | Bone Graft Substitute, 1-2mm Micro-Morsels Filled Canister, Beta-Tricalcium Phosphate |
| 00808232000023 | Bone Graft Substitute, Blocks, Beta-Tricalcium Phosphate |
| 00808232000016 | Bone Graft Substitute, Blocks, Beta-Tricalcium Phosphate |
| 07613327280258 | SPECIALTY FOAM PACK DELIVERY TOOL |
Trademark Results [Vitoss]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VITOSS 77714026 3766397 Live/Registered |
ORTHOVITA, INC. 2009-04-15 |
 VITOSS 77318463 3755209 Dead/Cancelled |
Orthovita, Inc. 2007-10-31 |
 VITOSS 75816534 2513277 Live/Registered |
ORTHOVITA, INC. 1999-10-06 |
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