Vitality Spinal Fixation System
FDA 510(k) clearance K150896 · decided 2015-08-31
Clearance details
- K-number
- K150896
- Device name
- Vitality Spinal Fixation System
- Applicant
- Zimmer Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-04-02
- Decision date
- 2015-08-31
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spi recall (Z-0639-2024) | Zimmer Biomet Spine Inc. | 2024-01-04 |
| Vitality Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pe recall (Z-0866-2019) | Zimmer Biomet Spine Inc. | 2019-02-22 |
| Vitality Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-steri recall (Z-0868-2019) | Zimmer Biomet Spine Inc. | 2019-02-22 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BAK VISTA INTERBODY FUSION CAGE (P950002/S014) | Zimmer Spine, Inc. | 2004-07-01 |
| VISTA LORDOTIC INTERBODY FUSION CAGE (P950002/S013) | Zimmer Spine, Inc. | 2004-01-29 |
| BAK VISTA INTERBODY FUSION CAGE (P950002/S012) | Zimmer Spine, Inc. | 2003-10-31 |
| BAK VISTA INTERBODY FUSION DEVICE (P950002/S011) | Zimmer Spine, Inc. | 2003-07-08 |
| BAK INTERBODY FUSION SYSTEM, BP/LORDOTIC DEVICE (P950002/S007) | Zimmer Spine, Inc. | 2002-05-01 |
| BAK/PROXIMITY(TM) INTERBODY FUSION SYSTEM (P950002/S009) | Zimmer Spine, Inc. | 2001-04-03 |
| BAK/L INTERBODY FUSION SYSTEM (P950002/S008) | Zimmer Spine, Inc. | 1999-12-20 |
| BAK INTERBODY FUSION SYSTEM (P950002/S006) | Zimmer Spine, Inc. | 1998-05-12 |