ALTAPORE 1508044
GUDID 00085412654386
Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate
Apatech Ltd
Bone matrix implant, synthetic| Primary Device ID | 00085412654386 |
| NIH Device Record Key | 878ebf8c-e835-4476-9713-a4b7e9a4ef49 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALTAPORE |
| Version Model Number | 1508044 |
| Catalog Number | 1508044 |
| Company DUNS | 221517829 |
| Company Name | Apatech Ltd |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
| Total Volume | 2.6 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00085412654386 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191513
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 | 2019-12-19 |
| Device Publish Date | 2019-12-11 |
On-Brand Devices [ALTAPORE]
| 05413760479002 | Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 05413760478999 | Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 05413760478982 | Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 05413760478975 | Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 05413760478968 | Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 00085412654393 | Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 00085412654386 | Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 00085412654379 | Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 00085412654362 | Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 00085412678146 | Bioactive and Osteoconductive - Silicate Substituted Calcium Phosphate bone void filler |
| 00085412630731 | Bioactive and Osteoconductive - Silicate Substituted Calcium Phosphate bone void filler |
Trademark Results [ALTAPORE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALTAPORE 87534623 not registered Live/Pending |
Baxter International Inc. 2017-07-19 |
 ALTAPORE 87165257 5633374 Live/Registered |
Baxter International Inc. 2016-09-08 |
 ALTAPORE 86064462 not registered Dead/Abandoned |
Baxter International Inc. 2013-09-13 |
 ALTAPORE 86008035 not registered Dead/Abandoned |
Baxter International Inc. 2013-07-11 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.