Ace Orthopedic Manufacturing Co.
Mchenry, IL, US
Ace Orthopedic Manufacturing Co. appears in FDA device records in Mchenry, IL. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Ace Orthopedic Manufacturing Co. between 1977 and 1994. The busiest year on record is 1978, with 4. The most recent is 1994, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 4 |
| 1979 | 1 |
| 1980 | 1 |
| 1981 | 1 |
| 1982 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K934962 | AIM SUPRACONDYLAR NAIL | HSB | Substantially Equivalent | |
| K934643 | ACE HUMERAL NAIL | HSB | Substantially Equivalent | |
| K936045 | ACE UNILATERAL FIXATOR II | JEC | Substantially Equivalent | |
| K926047 | ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW | HWC | Substantially Equivalent | |
| K920738 | ACE 100 DEGREES TUBULAR PLATE | HRS | Substantially Equivalent | |
| K813554 | ACE/KYLE CAPTURED HIP SCREW | KTT | Substantially Equivalent | |
| K810193 | TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG | HAX | Substantially Equivalent | |
| K801594 | ACE FISCHER EXTERNAL FIXATION DEVICE | HXK | Substantially Equivalent | |
| K791466 | ACE EXTERNAL BONE CLAMP PART #S11 | JEC | Substantially Equivalent | |
| K781841 | BAR, DISTRACTION | JEC | Substantially Equivalent | |
| K781840 | EXTERNAL ARTICULATION | JEC | Substantially Equivalent | |
| K781839 | BONE CLAMP, ACE EXTERNAL | JEC | Substantially Equivalent | |
| K781251 | THREADED PIN, SELF DRILLING | JDW | Substantially Equivalent | |
| K761229 | ANAL/RECTAL SYRINGE | KOA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- JECComponent, Traction, Invasive
- HXKHolder, Needle; Orthopedic
- JDWPin, Fixation, Threaded
- HRSPlate, Fixation, Bone
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- KOASurgical Instruments, G-U, Manual (And Accessories)
- HAXTong, Skull For Traction
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain