UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063
FDA 510(k) clearance K091190 · decided 2009-07-30
Clearance details
- K-number
- K091190
- Device name
- UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063
- Applicant
- Zimmer Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-04-23
- Decision date
- 2009-07-30
- Days to decision
- 98 days
- Clearance type
- Special
- Product code
- JDQ
- Device class
- 2
- Regulation number
- 888.3010
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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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 |