ANDREWS REMOTE CHUCK DRILL
FDA 510(k) clearance K831043 · decided 1983-04-28
Clearance details
- K-number
- K831043
- Device name
- ANDREWS REMOTE CHUCK DRILL
- Applicant
- Orthopedic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-31
- Decision date
- 1983-04-28
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- HXY
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, 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 |
|---|---|---|
| BENDEREV DRILL GUIDE (K923776) | Neimark Labs, Inc. | 1992-11-06 |
| MITEK DRILL GUIDE (K892904) | Mitek Surgical Products, Inc. | 1989-09-28 |
| BONE SUTURE FIXATION DEVICE (K880264) | Orthopedic Systems, Inc. | 1988-03-23 |
| TELOS DISTAL TARGETING DEVICE (K880381) | Austin Assoc. | 1988-03-15 |
| HASTING FINGER FIXATOR INSTRUMENTS (K880046) | Buckman Co., Inc. | 1988-02-16 |
| CEMENT EXTRACTOR DRILL (K770204) | Depuy, Inc. | 1977-02-08 |
Recalls involving this device
No recalls on record reference this clearance.