MODIFIED RONGEURS FOR SPINAL & ORTH. S.
FDA 510(k) clearance K821358 · decided 1982-05-28
Clearance details
- K-number
- K821358
- Device name
- MODIFIED RONGEURS FOR SPINAL & ORTH. S.
- Applicant
- Downs Surgical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1982-05-06
- Decision date
- 1982-05-28
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- EMH
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Downs Surgical
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 |
|---|---|---|
| BONE RONGEUR, DOUBLE-ACTION (K890256) | Kinetic Medical Products | 1989-01-27 |
| BONE RONGEUR, SINGLE-ACTION (K890255) | Kinetic Medical Products | 1989-01-27 |
| MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLAT (K854887) | Walter Lorenz Surgical, Inc. | 1986-02-28 |
| 586 TO 596 VARIOUS TYPES DENTAL ROOT SPLINTER FORC (K851710) | Artiberia | 1985-06-11 |
| JAKOBI SURG. INSTRUMENTS #8 15 (K834190) | Imm Enterprises , Ltd. | 1984-03-06 |
| SURGICAL INSTRUMENTS & ACCESSORIES (K834366) | C.B.S. Biotechnics, Inc. | 1984-02-27 |
| FORCEPS, STYLE #849 (K771522) | Premier Dental Products Co. | 1977-08-16 |
Recalls involving this device
No recalls on record reference this clearance.