SYNTHES T-PAL SPACER
FDA 510(k) clearance K100089 · decided 2010-05-13
Clearance details
- K-number
- K100089
- Device name
- SYNTHES T-PAL SPACER
- Applicant
- Synthes Spine
- Decision
- Substantially Equivalent
- Date received
- 2010-01-12
- Decision date
- 2010-05-13
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- West Chester, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Synthes 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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer syste recall (Z-0161-2012) | Synthes USA (HQ), Inc. | 2011-11-04 |