Aesculap Bone Wax
FDA 510(k) K000021 · Aesculap, Inc.
510(k) numberK000021
Submission
- Device name
- Aesculap Bone Wax
- Applicant
- Aesculap, Inc.
San Diego, CA, US - Received
- January 4, 2000
- Decision date
- March 24, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MTJ – Wax, Bone
- Device class
- Unclassified
- Implant
- Yes
Other 510(k)s with product code MTJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262769 | Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)MTJ · Special | Orthocon, Inc. | 09/03/2026SE |
| K261439 | Permatage Flowable, Settable Hemostatic Bone PasteMTJ · Traditional | Orthocon, Inc. | 06/03/2026SE |
| K232998 | Montage- XT Settable, Resorbable Hemostatic Bone PuttyMTJ · Special | Orthocon, Inc. | 10/12/2023SE |
| K213418 | MONTAGE Settable, Resorbable Hemostatic Bone PuttyMTJ · Traditional | Orthocon, Inc. | 08/30/2023SE |
| K231386 | Montage Flowable XRO Settable, Resorbable Hemostatic Bone PasteMTJ · Traditional | Orthocon, Inc. | 07/11/2023SE |
| K200452 | Meril-BonewaxMTJ · Traditional | M/s. Meril Endo Surgery Private Limited. | 03/27/2023SE |
| K220315 | MONTAGE-XT Settable, Resorbable Hemostatic Bone PuttyMTJ · Traditional | Orthocon, Inc. | 03/11/2022SE |
| K202363 | HBP7 Settable Hemostatic Bone PuttyMTJ · Traditional | Orthocon, Inc. | 01/19/2021SE |
| K193052 | HBP6 Settable, Resorbable Hemostatic Bone PasteMTJ · Traditional | Orthocon, Inc. | 03/27/2020SE |
| K191140 | MONTAGE-QS Settable, Resorbable Hemostatic BoneMTJ · Traditional | Orthocon, Inc. | 07/18/2019SE |
More from Orthocon, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K242762 | Aesculap Aicon® Series Container SystemKCT · Traditional | 05/13/2025SE |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetJXG · Traditional | 12/16/2024SE |
| K223596 | SQ.line KERRISONHAE · Traditional | 06/29/2023SE |
| K214041 | Aesculap AICON ContainerKCT · Traditional | 12/30/2022SE |
| K211572 | Aesculap Slim Clip ApplierHCI · Traditional | 12/13/2021SE |
| K203739 | ELAN 4 Electro Motor SystemHBE · Traditional | 08/24/2021SE |
| K202391 | Dir 800IZI · Traditional | 01/21/2021SE |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology SystemGEI · Special | 12/18/2020SE |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology SystemGEI · Special | 10/30/2020SE |
| K202124 | Aesculap PAS-Port Proximal Anastomosis SystemFZP · Special | 09/02/2020SE |
Questions and answers
When was Aesculap Bone Wax cleared by the FDA?
Aesculap Bone Wax (K000021) received a 510(k) decision of Substantially Equivalent on March 24, 2000, 80 days after the submission was received.
What is the product code of K000021?
The FDA product code is MTJ – Wax, Bone, a Unclassified device.