Solstice Cross Connector
FDA 510(k) K120998 · Life Spine
510(k) numberK120998
Submission
- Device name
- Solstice Cross Connector
- Applicant
- Life Spine
Hoffman Estates, IL, US - Received
- April 2, 2012
- Decision date
- October 1, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3050
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143278 | LnK Posterior Cervical Fixation SystemKWP · Traditional | L&K BIOMED Co., Ltd. | 07/29/2015SE |
| K150753 | OASYS SystemKWP · Traditional | Stryker Corporation | 06/09/2015SE |
| K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWP · Special | Precision Spine, Inc. | 06/04/2015SE |
| K142867 | Reliance Posterior Cervical-Thoracic SystemKWP · Special | Reliance Medical Systems, LLC | 04/29/2015SE |
| K150254 | Streamline OCT Occipito-Cervico-Thoracic SystemKWP · Traditional | Pioneer Surgical Technology, Inc. (Dba Rti… | 04/28/2015SE |
| K142253 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/23/2015SE |
| K150229 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K143249 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K142741 | OASYS SystemKWP · Traditional | Stryker Corporation | 01/15/2015SE |
| K142558 | Caspian OCT/MESA Mini/DENALI Mini Spinal SystemKWP · Special | K2m | 12/22/2014SE |
More from K2m
| 510(k) | Device | Decision |
|---|---|---|
| K261430 | TruLift Expandable SystemMAX · Traditional | 07/28/2026SE |
| K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsOLO · Traditional | 06/02/2026SE |
| K260837 | VersaLift Expandable SystemMAX · Traditional | 05/12/2026SE |
| K254274 | ARx® SAI Implant SystemNKB · Traditional | 04/16/2026SE |
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemMAX · Traditional | 01/23/2026SE |
| K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemMAX · Traditional | 07/07/2025SE |
| K250373 | ProLift Expandable Spacer SystemMAX · Traditional | 04/09/2025SE |
| K243668 | ProLift Pivot Expandable Spacer SystemMAX · Traditional | 01/23/2025SE |
| K243369 | Cervical Plating SystemKWQ · Traditional | 12/11/2024SE |
| K242826 | ProLift Wedge Expandable Spacer SystemMAX · Traditional | 10/08/2024SE |
Questions and answers
When was Solstice Cross Connector cleared by the FDA?
Solstice Cross Connector (K120998) received a 510(k) decision of Substantially Equivalent on October 1, 2012, 182 days after the submission was received.
What is the product code of K120998?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.