OsteoVation Impact
FDA 510(k) clearance K162864 · decided 2017-01-13
Clearance details
- K-number
- K162864
- Device name
- OsteoVation Impact
- Applicant
- Skeletal Kinetics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-10-13
- Decision date
- 2017-01-13
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- GXP
- Device class
- 2
- Regulation number
- 882.5300
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Cupertino, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Skeletal Kinetics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TnR Cranial Implant (K251959) | T&R BIOFAB CO., Ltd. | 2026-07-30 |
| Permatage XT Settable Bone Putty (K261265) | Orthocon, Inc. | 2026-06-15 |
| Permatage Flowable, Settable Bone Paste (K253732) | Orthocon, Inc. | 2026-03-13 |
| MONTAGE XT Cranial Cement (K253854) | Orthocon, Inc. | 2026-01-02 |
| Permatage Settable Bone Putty (K241027) | Orthocon, Inc. | 2024-09-26 |
| Montage Flowable Settable, Resorbable Bone Paste (K232771) | Orthocon, Inc. | 2024-02-16 |
| MONTAGE-QS Settable, Resorbable Bone Putty (K231475) | Orthocon, Inc. | 2023-10-12 |
| MONTAGE Settable, Resorbable Bone Putty (K221933) | Orthocon, Inc. | 2023-01-13 |
| DB-CMF (K182742) | Dimensional Bioceramics, LLC | 2019-06-20 |
| DirectInject (K143661) | Stryker | 2015-09-02 |
| NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY (K102018) | Synthes USA Products, LLC | 2010-09-23 |
| KRYPTONITE BONE CEMENT (K091382) | Doctors Research Group, Inc. | 2009-11-16 |
Recalls involving this device
No recalls on record reference this clearance.