DIAO HAND SURGERY SET
FDA 510(k) clearance K960539 · decided 1996-07-23
Clearance details
- K-number
- K960539
- Device name
- DIAO HAND SURGERY SET
- Applicant
- Kinetikos Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-02-07
- Decision date
- 1996-07-23
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- HXB
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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|---|---|---|
| COHORT AVB RETRACTOR SYSTEM (K943472) | Cohort Medical Products Group, Inc. | 1994-10-20 |
| FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE (K912843) | Flexmedics | 1991-09-24 |
| SURGICAL PROBE (K890227) | Kinetic Medical Products | 1989-01-27 |
| HOOK PROBE #TM-1376 (K873652) | Arthropedics, Inc. | 1987-11-02 |
| BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375 (K873651) | Arthropedics, Inc. | 1987-11-02 |
| BOWEN PROBE (K863149) | Bowen & Company, Inc. | 1986-09-05 |
| 2.5MM & 4MM PROBE K841969-LABELING (K841971) | Stainless Mfg., Inc. | 1984-06-19 |
| SHUTT PRECISION PROBES (K840558) | Concept, Inc. | 1984-04-25 |
| LINE CADDY (K810294) | Instranetics, Inc. | 1981-02-26 |
| I.M PROBES (K802951) | Hogan & Hartson | 1980-12-17 |
| SURGICAL KNIVES & PROBES (K802479) | Eder Instrument Co, Inc. | 1980-10-31 |
| PROBE (K800729) | Stainless Mfg., Inc. | 1980-04-08 |
Recalls involving this device
No recalls on record reference this clearance.