UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
FDA 510(k) clearance K142053 · decided 2014-10-29
Clearance details
- K-number
- K142053
- Device name
- UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
- Applicant
- Zimmer Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-07-29
- Decision date
- 2014-10-29
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- OWI
- Device class
- 2
- Regulation number
- 888.3010
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Zimmer Spine
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LigaPASS™ System (K261374) | Medicrea International S.A.S | 2026-05-27 |
| Invictus Bands System (K253615) | Alphatec Spine, Inc. | 2026-03-25 |
| OLYMPIC Deformity Band System (K222097) | Astura Medical | 2023-05-04 |
| HILINE™ Fixation System (K230565) | Globus Medical, Inc. | 2023-04-20 |
| LigaPASS™ 2.0 Ligament Augmentation System (K213659) | Medicrea International SA | 2022-05-24 |
| LigaPASS® Spinal System, CD Horizon™ Spinal System (K211057) | Medtronic, Inc. | 2021-05-27 |
| Mariner Cap System (K201240) | SeaSpine Orthopedics Corporation | 2020-08-05 |
| The Gecko Spinal System (K200281) | Ortho Development Corporation | 2020-03-31 |
| Response BandLoc Spinal Fixation (K200097) | OrthoPediatrics Corp. | 2020-03-16 |
| JAZZ PF (K191217) | Implanet, S.A. | 2019-08-02 |
| Karma® Fixation System (K190289) | Spinal Elements, Inc. | 2019-04-03 |
| NuVasive® VersaTie® System (K190418) | Nu Vasive, Incorporated | 2019-03-21 |
Recalls involving this device
No recalls on record reference this clearance.
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 |