L-VARLOCK
FDA 510(k) clearance K080537 · decided 2008-06-30
Clearance details
- K-number
- K080537
- Device name
- L-VARLOCK
- Applicant
- Kiscomedica S.A.
- Decision
- Substantially Equivalent
- Date received
- 2008-02-27
- Decision date
- 2008-06-30
- Days to decision
- 124 days
- Clearance type
- Traditional
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Round Rock, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Kiscomedica S.A.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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 |
|---|---|---|
| L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Produc recall (Z-1461-2017) | Kiscomedica S.A. | 2017-02-27 |