SpaceFlex Acetabular Cup
FDA 510(k) K223441 · G21, S.R.L.
510(k) numberK223441
Submission
- Device name
- SpaceFlex Acetabular Cup
- Applicant
- G21, S.R.L.
San Possidonio, IT - Received
- November 14, 2022
- Decision date
- March 23, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3390
- Specialty
- Orthopedic
- Implant
- Yes
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More from Implantcast GmbH
| 510(k) | Device | Decision |
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| K252443 | SpaceFix Shoulder SpacerMBB · Traditional | 09/15/2025SE |
| K202338 | SpaceFlex ShoulderMBB · Traditional | 02/17/2021SE |
| K201960 | SpaceFlex Knee - 80mm SizeMBB · Special | 08/13/2020SE |
| K193061 | G3 40 Radiopaque Bone CementLOD · Traditional | 03/19/2020SE |
| K193059 | G1 40 Radiopaque Bone CementLOD · Traditional | 03/19/2020SE |
| K192041 | G21 SpaceFlex HipMBB · Traditional | 10/29/2019SE |
| K190216 | SpaceFlex KneeMBB · Traditional | 06/09/2019SE |
| K181282 | G3A 40 Bone CementLOD · Traditional | 01/09/2019SE |
| K173494 | OrthoSteady G Bone CementLOD · Traditional | 03/06/2018SE |
| K152557 | Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon CathetersNDN · Traditional | 02/23/2016SE |
Questions and answers
When was SpaceFlex Acetabular Cup cleared by the FDA?
SpaceFlex Acetabular Cup (K223441) received a 510(k) decision of Substantially Equivalent on March 23, 2023, 129 days after the submission was received.
What is the product code of K223441?
The FDA product code is KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3390.