Whiteside Biomechanics Spinal System
FDA 510(k) K991678 · Whiteside Biomechanics, Inc.
510(k) numberK991678
Submission
- Device name
- Whiteside Biomechanics Spinal System
- Applicant
- Whiteside Biomechanics, Inc.
Creve Coeur, MO, US - Received
- May 17, 1999
- Decision date
- August 12, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
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More from Carlsmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K033313 | Quatro M Femoral ComponentLWJ · Traditional | 07/28/2004SE |
| K012800 | Symmetric Unicompartmental Knee SystemHRY · Traditional | 05/03/2002SE |
| K003618 | Whiteside Biomechanics Low Profile Stainless Steel Cable System, Model BIO-1-1014NDD · Traditional | 05/23/2001SE |
| K993903 | Whiteside Biomechanics Titanium Low-Profile Cable, Model BIO-1-1013JDQ · Traditional | 02/14/2000SE |
| K981238 | Bipolar Femoral HeadKWY · Traditional | 08/21/1998SE |
| K973261 | Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral HeadLZO · Traditional | 11/24/1997SE |
| K964616 | Quatroloc Plasma Sprayed Femoral ComponentLPH · Traditional | 08/07/1997SE |
| K971721 | Whiteside Biomechanics, Inc. Zirconia Ceramic Femoral HeadLZO · Traditional | 07/30/1997SE |
| K971718 | Micro-Seal Acetabular SystemLPH · Traditional | 07/23/1997SE |
| K964150 | Whiteside Biomechanics Zirconia Ceramic Femoral HeadLZO · Traditional | 12/27/1996SE |
Questions and answers
When was Whiteside Biomechanics Spinal System cleared by the FDA?
Whiteside Biomechanics Spinal System (K991678) received a 510(k) decision of Substantially Equivalent on August 12, 1999, 87 days after the submission was received.
What is the product code of K991678?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.