Aesculap Spine System Additional Components
FDA 510(k) K980121 · Aesculap, Inc.
510(k) numberK980121
Submission
- Device name
- Aesculap Spine System Additional Components
- Applicant
- Aesculap, Inc.
South San Francisco, CA, US - Received
- January 14, 1998
- Decision date
- June 10, 1998
- 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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| K223596 | SQ.line KERRISONHAE · Traditional | 06/29/2023SE |
| K214041 | Aesculap AICON ContainerKCT · Traditional | 12/30/2022SE |
| K211572 | Aesculap Slim Clip ApplierHCI · Traditional | 12/13/2021SE |
| K203739 | ELAN 4 Electro Motor SystemHBE · Traditional | 08/24/2021SE |
| K202391 | Dir 800IZI · Traditional | 01/21/2021SE |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology SystemGEI · Special | 12/18/2020SE |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology SystemGEI · Special | 10/30/2020SE |
| K202124 | Aesculap PAS-Port Proximal Anastomosis SystemFZP · Special | 09/02/2020SE |
Questions and answers
When was Aesculap Spine System Additional Components cleared by the FDA?
Aesculap Spine System Additional Components (K980121) received a 510(k) decision of Substantially Equivalent on June 10, 1998, 147 days after the submission was received.
What is the product code of K980121?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.