CaP Spheres Pellet Pack
FDA 510(k) K203218 · Zimmer Biomet Spine, Inc.
510(k) numberK203218
Submission
- Device name
- CaP Spheres Pellet Pack
- Applicant
- Zimmer Biomet Spine, Inc.
Westminister, CO, US - Received
- November 2, 2020
- Decision date
- May 4, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQV – Filler, Bone Void, Calcium Compound
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3045
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MQV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262230 | Mg OSTEOREVIVE;Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 09/11/2026SE |
| K260364 | Device 300419 StripMQV · Traditional | Geistlich Pharma AG | 06/02/2026SE |
| K252797 | JAZBI Resorbable Bone Void FillerMQV · Traditional | Sdip Innovations Pty, Ltd. | 05/26/2026SE |
| K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…MQV · Special | Stryker Spine | 04/24/2026SE |
| K253524 | Adaptos®Fuse Bone GraftMQV · Traditional | Biomendex OY | 02/17/2026SE |
| K253147 | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft…MQV · Special | Prosidyan, Inc. | 10/22/2025SE |
| K251522 | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 10/13/2025SE |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)MQV · Traditional | Wright Medical Technology, Inc. (Stryker… | 09/30/2025SE |
| K251556 | Device 300423 GranulesMQV · Traditional | Geistlich Pharma AG | 07/17/2025SE |
| K251720 | OsteoFlo HydroFiberMQV · Special | SurGenTec, LLC | 07/02/2025SE |
More from SurGenTec, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K212023 | Virage Navigation SystemOLO · Traditional | 08/27/2021SE |
| K210275 | Polaris Spinal SystemNKB · Special | 04/02/2021SE |
| K203507 | Vitality® Spinal Fixation SystemNKB · Traditional | 01/28/2021SE |
| K202309 | Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero…KWQ · Traditional | 10/08/2020SE |
| K191722 | Vital Navigation SystemOLO · Traditional | 12/02/2019SE |
| K192133 | Zimmer Biomet Universal Navigation SystemOLO · Traditional | 10/29/2019SE |
| K190556 | Zimmer Biomet Universal Navigation SystemOLO · Traditional | 10/24/2019SE |
| K183550 | Vitality® Spinal Fixation SystemNKB · Traditional | 04/08/2019SE |
| K181096 | Avenue P Cage SystemOVD · Traditional | 01/15/2019SE |
| K180227 | Polaris Spinal Growth SystemPGM · Traditional | 03/15/2018SE |
Questions and answers
When was CaP Spheres Pellet Pack cleared by the FDA?
CaP Spheres Pellet Pack (K203218) received a 510(k) decision of Substantially Equivalent on May 4, 2021, 183 days after the submission was received.
What is the product code of K203218?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.