OSTEOSET
GUDID 00840420133595
WRIGHT MEDICAL TECHNOLOGY, INC.
Bone matrix implant, synthetic| Primary Device ID | 00840420133595 |
| NIH Device Record Key | 515b41ac-45ae-46a2-8727-f47d771bc374 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSTEOSET |
| Version Model Number | 86003005 |
| Company DUNS | 807201207 |
| Company Name | WRIGHT MEDICAL TECHNOLOGY, INC. |
| 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 | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com |
Device Dimensions
| Weight | 5 Gram |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 5 Gram |
| Total Volume | 5 Milliliter |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 5 Gram |
| Total Volume | 5 Milliliter |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 5 Gram |
| Total Volume | 5 Milliliter |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 5 Gram |
| Total Volume | 5 Milliliter |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 5 Gram |
| Total Volume | 5 Milliliter |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 5 Gram |
| Total Volume | 5 Milliliter |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 5 Gram |
| Total Volume | 5 Milliliter |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 5 Gram |
| Total Volume | 5 Milliliter |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 5 Gram |
| Total Volume | 5 Milliliter |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 5 Gram |
| Total Volume | 5 Milliliter |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 5 Gram |
| Total Volume | 5 Milliliter |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 5 Gram |
| Total Volume | 5 Milliliter |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 5 Gram |
| Total Volume | 5 Milliliter |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 5 Gram |
| Total Volume | 5 Milliliter |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 5 Gram |
| Total Volume | 5 Milliliter |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 5 Gram |
| Total Volume | 5 Milliliter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| 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 | 00840420133595 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K022828
FDA Product Code
| MBP | Filler, bone void, osteoinduction (w/o human growth factor) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-15 |
On-Brand Devices [OSTEOSET]
| 00840420123824 | 84000106 |
| 00840420123817 | 84000104 |
| 00840420123800 | 84000102 |
| 00840420123794 | 84000101 |
| 00840420140821 | 84SR4V02 |
| 00840420135629 | 84SR4V10 |
| 00840420135612 | 84SR4V05 |
| 00840420135605 | 84SR4820 |
| 00840420135599 | 84SR4805 |
| 00840420135582 | 84SR3001 |
| 00840420135551 | P0SR4805 |
| 00840420135544 | P0SR3001 |
| 00840420133687 | 84000611 |
| 00840420133670 | 84000511 |
| 00840420133656 | 91004805 |
| 00840420133649 | 87004805 |
| 00840420133632 | 87003012 |
| 00840420133625 | 86004810 |
| 00840420133618 | 86004805 |
| 00840420133601 | 86003010 |
| 00840420133595 | 86003005 |
| 00840420133489 | 84000311 |
| 00840420133472 | 84000310 |
| 00840420133465 | 84000305 |
| 00840420133434 | 84000211 |
| 00840420133441 | Bead Mold |
Trademark Results [OSTEOSET]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSTEOSET 74692159 2031137 Live/Registered |
Wright Medical Technology, Inc. 1995-06-22 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.