ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE
FDA 510(k) clearance K940480 · decided 1994-03-23
Clearance details
- K-number
- K940480
- Device name
- ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE
- Applicant
- Acufex Microsurgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-02-02
- Decision date
- 1994-03-23
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- HTJ
- Device class
- 1
- Regulation number
- 888.4300
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mansfield, MA, 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 |
|---|---|---|
| ACUFEX INTRA ARTICULAR MEASURING DEVICE (K925335) | Acufex Microsurgical, Inc. | 1992-12-29 |
| ACROMED INTERBODY DEPTH GAUGES (K873191) | Buckman Co., Inc. | 1987-09-09 |
| RAYLOR(TM) DEPTH GAUGE (K864426) | Cedar Surgical, Inc. | 1986-11-26 |
Recalls involving this device
No recalls on record reference this clearance.