OsteoBallast™ 56800160
GUDID 10889981189266
OsteoBallast, 115 x11mm
SEASPINE ORTHOPEDICS CORPORATION
Bone matrix implant, human-derived| Primary Device ID | 10889981189266 |
| NIH Device Record Key | cc09c4cc-3807-4c54-bd06-7904b23a9edc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OsteoBallast™ |
| Version Model Number | 56800160 |
| Catalog Number | 56800160 |
| Company DUNS | 079840876 |
| Company Name | SEASPINE ORTHOPEDICS 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 | true |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| 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(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981189266 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K193040
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-06 |
| Device Publish Date | 2023-08-29 |
Devices Manufactured by SEASPINE ORTHOPEDICS CORPORATION
| 00889981124017 - Shoreline ACS | 2024-12-30 No Profile Spacer, 16x14x6mm, 7 Degree, Sterile |
| 00889981124024 - Shoreline ACS | 2024-12-30 No Profile Spacer, 16x14x7mm, 7 Degree, Sterile |
| 00889981124031 - Shoreline ACS | 2024-12-30 No Profile Spacer, 16x14x8mm, 7 Degree, Sterile |
| 00889981124048 - Shoreline ACS | 2024-12-30 No Profile Spacer, 16x14x9mm, 7 Degree, Sterile |
| 00889981124055 - Shoreline ACS | 2024-12-30 No Profile Spacer, 16x14x10mm, 7 Degree, Sterile |
| 00889981124062 - Shoreline ACS | 2024-12-30 No Profile Spacer, 16x14x11mm, 7 Degree, Sterile |
| 00889981124079 - Shoreline ACS | 2024-12-30 No Profile Spacer, 16x14x12mm, 7 Degree, Sterile |
| 00889981124086 - Shoreline ACS | 2024-12-30 No Profile Spacer, 18x15x6mm, 7 Degree, Sterile |
Trademark Results [OsteoBallast]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSTEOBALLAST 87584010 5728747 Live/Registered |
IsoTis OrthoBiologics, Inc. 2017-08-25 |
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