FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACE FISCHER EXTERNAL FIXATION DEVICE
K Number: K801594
·
Decision Sep 9, 1980
Classifications
1
FEI Numbers
241
Registration Numbers
241
Same Product Code
4
Applicant Total
14
Review Days
57
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ACE FISCHER EXTERNAL FIXATION DEVICE
- K Number
- K801594
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Ace Orthopedic Manufacturing Co.
- Date Received
- July 14, 1980
- Decision Date
- September 9, 1980
- Product Code
- HXK
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HXK | Holder, Needle; Orthopedic | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HXK), ordered by most recent decision date.
HOLDER, NEEDLE
FDA 510(k)
FDA Class 1
·Orthopedic
MICRINS NEEDLE HOLDER
FDA 510(k)
FDA Class 1
·Orthopedic
FISCHER WIRE/PIN CLAMP
FDA 510(k)
FDA Class 1
·Orthopedic
CONVERSE-GILLIES NEEDLE HOLDER
FDA 510(k)
FDA Class 1
·Orthopedic
Other Clearances by Ace Orthopedic Manufacturing Co.
| K Number | Device Name | ||
|---|---|---|---|
| K934643 | ACE HUMERAL NAIL | Mar 22, 1994 | Substantially Equivalent |
| K934962 | AIM SUPRACONDYLAR NAIL | Mar 22, 1994 | Substantially Equivalent |
| K936045 | ACE UNILATERAL FIXATOR II | Feb 22, 1994 | Substantially Equivalent |
| K926047 | ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW | Mar 31, 1993 | Substantially Equivalent |
| K920738 | ACE 100 DEGREES TUBULAR PLATE | Jul 27, 1992 | Substantially Equivalent |
| K813554 | ACE/KYLE CAPTURED HIP SCREW | Jan 12, 1982 | Substantially Equivalent |
| K810193 | TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG | Mar 20, 1981 | Substantially Equivalent |
| K791466 | ACE EXTERNAL BONE CLAMP PART #S11 | Aug 16, 1979 | Substantially Equivalent |
| K781839 | BONE CLAMP, ACE EXTERNAL | Nov 8, 1978 | Substantially Equivalent |
| K781840 | EXTERNAL ARTICULATION | Nov 8, 1978 | Substantially Equivalent |