ENDO HEAD
FDA 510(k) clearance K111145 · decided 2011-08-16
Clearance details
- K-number
- K111145
- Device name
- ENDO HEAD
- Applicant
- Medacta International
- Decision
- Substantially Equivalent
- Date received
- 2011-04-22
- Decision date
- 2011-08-16
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- LZY
- Device class
- 2
- Regulation number
- 888.3360
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Camarillo, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medacta International
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.
| Record | Firm | Date |
|---|---|---|
| TANDEM Hip System (K231448) | Smith & Nephew, Inc. | 2023-07-19 |
| PRE-POWDERED NITRILE EXAMINATION GLOVES (K974442) | P.T. Latexindo Tobaperkasa | 1998-01-05 |
| BHR BIPOLAR FEMORAL HEAD COMPONENT (K915528) | Implantology Corp. | 1993-06-29 |
| IONGUARD TITANIUM MODULAR HEADS (K915548) | Biomet, Inc. | 1992-03-10 |
| MODULAR CATHCART FRACTURE SYSTEM (K903084) | Depuy, Inc. | 1990-10-03 |
| UNI-POLAR HEAD (K896580) | Richards Medical Co., Inc. | 1990-02-15 |
| FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR (K892059) | Protek, Inc. | 1989-07-19 |
Recalls involving this device
No recalls on record reference this clearance.