Skaffold Cis
FDA 510(k) K111538 · Skeletal Kinetics, LLC
510(k) numberK111538
Submission
- Device name
- Skaffold Cis
- Applicant
- Skeletal Kinetics, LLC
Cupertino, CA, US - Received
- June 2, 2011
- Decision date
- October 25, 2011
- 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
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| 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 |
|---|---|---|
| K162864 | OsteoVation ImpactGXP · Traditional | 01/13/2017SE |
| K132211 | Skaffold NMX Bone Void FillerMQV · Traditional | 08/04/2014SE |
| K120354 | Beta-Tcp GranulesMQV · Traditional | 03/21/2013SE |
| K112383 | Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void FillerMQV · Traditional | 02/07/2012SE |
| K100986 | Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo VationMQV · Traditional | 07/20/2010SE |
| K051784 | Osteovation CMF Bone Void FillerGXP · Special | 07/20/2005SE |
| K051123 | Callos Impact and Inject Bone Void FillerMQV · Special | 06/03/2005SE |
| K042072 | Callos CMF Bone Void FillerGXP · Traditional | 09/16/2004SE |
| K030554 | CallosMQV · Traditional | 05/20/2003SE |
Questions and answers
When was Skaffold Cis cleared by the FDA?
Skaffold Cis (K111538) received a 510(k) decision of Substantially Equivalent on October 25, 2011, 145 days after the submission was received.
What is the product code of K111538?
The FDA product code is MTJ – Wax, Bone, a Unclassified device.