ACROMED BONE SCREW TAP SLEEVES
FDA 510(k) clearance K873067 · decided 1987-09-02
Clearance details
- K-number
- K873067
- Device name
- ACROMED BONE SCREW TAP SLEEVES
- Applicant
- Buckman Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-08-05
- Decision date
- 1987-09-02
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- HWX
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Martinez, 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 |
|---|---|---|
| FEMORAL CEMENT REMOVAL INSTRUMENT (K840735) | Amtech Scientific, Inc. | 1984-05-14 |
Recalls involving this device
No recalls on record reference this clearance.