Callos CALL-PA10
GUDID 00813845020665
SK Callos, Impact 10cc
SKELETAL KINETICS LLC
Bone matrix implant, synthetic| Primary Device ID | 00813845020665 |
| NIH Device Record Key | 57e9c462-9713-437c-841a-a0bfaaa23680 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Callos |
| Version Model Number | CALL-PA10 |
| Catalog Number | CALL-PA10 |
| Company DUNS | 140071411 |
| Company Name | SKELETAL KINETICS LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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(972)677-4655 |
| cs@skeletalkinetics.com | |
| Phone | +1(972)677-4655 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com |
Device Dimensions
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813845020665 [Primary] |
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 | 2018-06-29 |
| Device Publish Date | 2015-10-30 |
On-Brand Devices [Callos]
| 00813845020672 | SK, Impact 25cc |
| 00813845020665 | SK Callos, Impact 10cc |
| 00813845020658 | SK, Callos, Impact 5cc |
| 00813845020641 | SK, Callos, Inject 10cc |
| 00813845020634 | SK, Callos, Inject 5cc |
| 00813845020627 | SK Callos Impact (MX), 10cc |
| 00813845020610 | SK Callos Impact (MX), 5cc |
| 00813845020603 | SK Callos Inject (MX) 10cc |
| 00813845020597 | SK Callos Inject (MX), 5cc |
| 00813845020580 | SK Callos Inject (MX), 3cc |
| 00813845020269 | Acumed Callos, Impact 10cc |
| 00813845020252 | Acumed, Callos, Impact 5cc |
| 00813845020245 | Acumed, Callos, Inject 10cc |
| 00813845020238 | Acumed, Callos, Inject 5cc |
| 00813845020221 | Acumed, Callos, Inject 3cc |
Trademark Results [Callos]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CALLOS 86717818 not registered Dead/Abandoned |
Foley Family Wines, Inc. 2015-08-07 |
 CALLOS 76470168 2929312 Live/Registered |
SK RESEARCH AND DEVELOPMENT, LLC 2002-11-25 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.