TRACER BONE MILL
FDA 510(k) clearance K883183 · decided 1988-10-12
Clearance details
- K-number
- K883183
- Device name
- TRACER BONE MILL
- Applicant
- De Medica Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-07-28
- Decision date
- 1988-10-12
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- LYS
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Santa Paula, 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 |
|---|---|---|
| ORTHOBLEND POWERED BONE MILL (K860356) | Zimmer, Inc. | 1986-07-08 |
| OSTEOMILL BONE GRINDER (K861164) | Biodynamic Technologies, Inc. | 1986-05-02 |
| AESCULAP BONE MILL (K860016) | Aesculap Instruments Corp. | 1986-03-19 |
Recalls involving this device
No recalls on record reference this clearance.