TENSION-ISOMETER
FDA 510(k) clearance K854254 · decided 1985-11-15
Clearance details
- K-number
- K854254
- Device name
- TENSION-ISOMETER
- Applicant
- Medmetric Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-10-22
- Decision date
- 1985-11-15
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- LXI
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SYNVASIVE CERAMIC SUTTING BLOCK (K930573) | Synvasive Technology, Inc. | 1994-04-07 |
| VILLAN (VIDEO LIFT LINK ANALYSIS) (K910712) | Physio Systems, Inc. | 1991-05-21 |
| ACL DRILL GUIDE SYSTEM (K892655) | Baxter Healthcare Corp | 1989-09-28 |
| PERSONAL ALERT ASSIST DEVICE (K890445) | Silent Call Corp. | 1989-05-19 |
| BOW & ARROW DRILL GUIDE (K882407) | Instrument Makar, Inc. | 1988-09-06 |
| PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE (K881378) | Pfizer, Inc. | 1988-06-17 |
| DYONICS DRILL GUIDE/ISOMETER SYSTEM (K880739) | Dyonics, Inc. | 1988-03-21 |
Recalls involving this device
No recalls on record reference this clearance.