BONE-TEMNO/STERNUM-TEMNO
FDA 510(k) clearance K913306 · decided 1991-11-01
Clearance details
- K-number
- K913306
- Device name
- BONE-TEMNO/STERNUM-TEMNO
- Applicant
- Proact, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1991-07-25
- Decision date
- 1991-11-01
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- LWE
- Device class
- 2
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- State College, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Proact
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 |
|---|---|---|
| JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN) (K952350) | Promedical , Ltd. | 1995-07-17 |
| BONE MARROW COLLECTION KIT AND STAND (K871198) | Baxter Healthcare Corp | 1987-11-06 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Orthofix Bone Marrow Aspiration Needle, Catalog number 21-5000, 21-5011, Distributed By: O recall (Z-0590-2011) | Orthofix Inc | 2010-12-10 |