Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod, Gibralt Occipital Plates
FDA 510(k) K121877 · Exactech, Inc.
510(k) numberK121877
Submission
- Device name
- Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod, Gibralt Occipital Plates
- Applicant
- Exactech, Inc.
Gainesville, FL, US - Received
- June 28, 2012
- Decision date
- February 12, 2013
- 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
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|---|---|---|---|
| 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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Questions and answers
When was Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod, Gibralt Occipital Plates cleared by the FDA?
Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod, Gibralt Occipital Plates (K121877) received a 510(k) decision of Substantially Equivalent on February 12, 2013, 229 days after the submission was received.
What is the product code of K121877?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.