FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BONE CLAMP, ACE EXTERNAL
K Number: K781839
·
Decision Nov 8, 1978
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
84
Applicant Total
14
Review Days
12
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Basic Information
- Device Name
- BONE CLAMP, ACE EXTERNAL
- K Number
- K781839
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Ace Orthopedic Manufacturing Co.
- Date Received
- October 27, 1978
- Decision Date
- November 8, 1978
- Product Code
- JEC
- 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 |
|---|---|---|---|
| JEC | Component, Traction, Invasive | FDA class 2 | Orthopedic |
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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 |
| K801594 | ACE FISCHER EXTERNAL FIXATION DEVICE | Sep 9, 1980 | Substantially Equivalent |
| K791466 | ACE EXTERNAL BONE CLAMP PART #S11 | Aug 16, 1979 | Substantially Equivalent |
| K781840 | EXTERNAL ARTICULATION | Nov 8, 1978 | Substantially Equivalent |