Bridgepoint Spinous Process Camp- Posterior Fixation System
FDA 510(k) K103205 · Alphatec Spine, Inc.
510(k) numberK103205
Submission
- Device name
- Bridgepoint Spinous Process Camp- Posterior Fixation System
- Applicant
- Alphatec Spine, Inc.
Carlsbad, CA, US - Received
- November 1, 2010
- Decision date
- June 2, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
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| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)KWQ · Traditional | 08/28/2025SE |
| K251080 | IdentiTi II Cervical Interbody SystemODP · Traditional | 07/03/2025SE |
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Questions and answers
When was Bridgepoint Spinous Process Camp- Posterior Fixation System cleared by the FDA?
Bridgepoint Spinous Process Camp- Posterior Fixation System (K103205) received a 510(k) decision of Substantially Equivalent on June 2, 2011, 213 days after the submission was received.
What is the product code of K103205?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.