PATELLAR COMPONENT FOR LUBINUS PATELLAR
FDA 510(k) clearance K800800 · decided 1980-04-21
Clearance details
- K-number
- K800800
- Device name
- PATELLAR COMPONENT FOR LUBINUS PATELLAR
- Applicant
- Waldemar Link GmbH & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 1980-04-10
- Decision date
- 1980-04-21
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- HTG
- Device class
- 2
- Regulation number
- 888.3580
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Waldemar Link GmbH & Co. KG
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 |
|---|---|---|
| WORRELL PATELLA (K771708) | Depuy, Inc. | 1977-10-06 |
Recalls involving this device
No recalls on record reference this clearance.