CERAMENT® G
GUDID 07350055430387
CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for use as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) where there is a need for supplemental bone graft. CERAMENT G combines gentamicin sulfate with a bone void filler, consisting of hydroxyapatite and calcium sulfate. By eluting gentamicin, CERAMENT G can reduce the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms in order to protect bone healing. By combining calcium sulfate and hydroxyapatite, a balance is achieved between implant resorption rate and bone remodeling rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate and high osteoconductivity providing a scaffold for new bone generation. The use of CERAMENT G eliminates the need to harvest autologous bone, thereby avoiding donor site morbidity (e.g., pain, infection, etc.) in patients with a diagnosed infection. CERAMENT G may be implanted by an injectable system or inserted as pre-set beads.
Bone Support AB
Bone matrix implant, synthetic, antimicrobial Bone matrix implant, synthetic, antimicrobial Bone matrix implant, synthetic, antimicrobial Bone matrix implant, synthetic, antimicrobial Bone matrix implant, synthetic, antimicrobial Bone matrix implant, synthetic, antimicrobial Bone matrix implant, synthetic, antimicrobial Bone matrix implant, synthetic, antimicrobial Bone matrix implant, synthetic, antimicrobial Bone matrix implant, synthetic, antimicrobial Bone matrix implant, synthetic, antimicrobial Bone matrix implant, synthetic, antimicrobial Bone matrix implant, synthetic, antimicrobial Bone matrix implant, synthetic, antimicrobial Bone matrix implant, synthetic, antimicrobial| Primary Device ID | 07350055430387 |
| NIH Device Record Key | bae66df1-4ba2-4113-9b16-e98adb4a1a7c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CERAMENT® G |
| Version Model Number | A0450-10 |
| Company DUNS | 350066052 |
| Company Name | Bone Support AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| 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 | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07350055430387 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN210044
FDA Product Code
| QRR | Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside |
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 | 2022-10-13 |
| Device Publish Date | 2022-10-05 |
On-Brand Devices [CERAMENT® G ]
| 07350055430387 | CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for u |
| 07350055430394 | CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for u |
| 07350055430530 | CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for u |
| 07350055430523 | CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for u |
Trademark Results [CERAMENT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CERAMENT 87150885 5604069 Live/Registered |
BoneSupport AB 2016-08-25 |
 CERAMENT 79020794 3298199 Live/Registered |
Bone Support AB 2005-11-10 |
 CERAMENT 77192160 3571152 Live/Registered |
Bone Support AB 2007-05-29 |
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