Company ยท US
Ace Orthopedic Manufacturing Co.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1994. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JEC | Component, Traction, Invasive | 5 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 |
| HAX | Tong, Skull For Traction | 1 |
| HRS | Plate, Fixation, Bone | 1 |
| HWC | Screw, Fixation, Bone | 1 |
| HXK | Holder, Needle; Orthopedic | 1 |
| JDW | Pin, Fixation, Threaded | 1 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 22, 1994 | K934962 | AIM SUPRACONDYLAR NAIL Ace Orthopedic Manufacturing Co. | HSB |
| Mar 22, 1994 | K934643 | ACE HUMERAL NAIL Ace Orthopedic Manufacturing Co. | HSB |
| Feb 22, 1994 | K936045 | ACE UNILATERAL FIXATOR II Ace Orthopedic Manufacturing Co. | JEC |
| Mar 31, 1993 | K926047 | ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW Ace Orthopedic Manufacturing Co. | HWC |
| Jul 27, 1992 | K920738 | ACE 100 DEGREES TUBULAR PLATE Ace Orthopedic Manufacturing Co. | HRS |
| Jan 12, 1982 | K813554 | ACE/KYLE CAPTURED HIP SCREW Ace Orthopedic Manufacturing Co. | KTT |
| Mar 20, 1981 | K810193 | TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG Ace Orthopedic Manufacturing Co. | HAX |
| Sep 9, 1980 | K801594 | ACE FISCHER EXTERNAL FIXATION DEVICE Ace Orthopedic Manufacturing Co. | HXK |
| Aug 16, 1979 | K791466 | ACE EXTERNAL BONE CLAMP PART #S11 Ace Orthopedic Manufacturing Co. | JEC |
| Nov 8, 1978 | K781841 | BAR, DISTRACTION Ace Orthopedic Manufacturing Co. | JEC |
| Nov 8, 1978 | K781840 | EXTERNAL ARTICULATION Ace Orthopedic Manufacturing Co. | JEC |
| Nov 8, 1978 | K781839 | BONE CLAMP, ACE EXTERNAL Ace Orthopedic Manufacturing Co. | JEC |
| Aug 31, 1978 | K781251 | THREADED PIN, SELF DRILLING Ace Orthopedic Manufacturing Co. | JDW |
| Feb 24, 1977 | K761229 | ANAL/RECTAL SYRINGE Ace Orthopedic Manufacturing Co. | KOA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||