ACE FISCHER EXTERNAL FIXATION DEVICE
FDA 510(k) clearance K801594 · decided 1980-09-09
Clearance details
- K-number
- K801594
- Device name
- ACE FISCHER EXTERNAL FIXATION DEVICE
- Applicant
- Ace Orthopedic Manufacturing Co.
- Decision
- Substantially Equivalent
- Date received
- 1980-07-14
- Decision date
- 1980-09-09
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- HXK
- 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 |
|---|---|---|
| HOLDER, NEEDLE (K890167) | Dhason Brothers, Inc. | 1989-02-03 |
| MICRINS NEEDLE HOLDER (K872989) | Micrins Surgical, Inc. | 1987-08-21 |
| FISCHER WIRE/PIN CLAMP (K860018) | Buckman Co., Inc. | 1986-02-07 |
| CONVERSE-GILLIES NEEDLE HOLDER (K772388) | Edward Weck, Inc. | 1978-01-20 |
Recalls involving this device
No recalls on record reference this clearance.