TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k) clearance K022344 · decided 2002-09-24
Clearance details
- K-number
- K022344
- Device name
- TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM
- Applicant
- Centerpulse Spine-Tech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-07-19
- Decision date
- 2002-09-24
- Days to decision
- 67 days
- Clearance type
- Special
- Product code
- KWQ
- Device class
- 2
- Regulation number
- 888.3060
- 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 |
|---|---|---|
| Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Z recall (Z-1014-04) | Zimmer Spine, Inc. | 2005-02-24 |