SLEEVE WITH ZIPLOOP FIXATION DEVICES
FDA 510(k) clearance K101063 · decided 2010-06-23
Clearance details
- K-number
- K101063
- Device name
- SLEEVE WITH ZIPLOOP FIXATION DEVICES
- Applicant
- Biomet Sports Medicine
- Decision
- Substantially Equivalent
- Date received
- 2010-04-16
- Decision date
- 2010-06-23
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Biomet Sports Medicine
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 |
|---|---|---|
| Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to ai recall (Z-1364-2015) | Biomet, Inc. | 2015-04-02 |