FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL
K Number: K972183
·
Decision Aug 26, 1997
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
21
Review Days
77
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Basic Information
- Device Name
- DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL
- K Number
- K972183
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ace Medical Co.
- Date Received
- June 10, 1997
- Decision Date
- August 26, 1997
- Product Code
- HSB
- 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 |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | FDA class 2 | Orthopedic |
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Other Clearances by Ace Medical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K955472 | ACE HUMERUS & RADIUS PLATES | Apr 1, 1996 | Substantially Equivalent |
| K955388 | ACE-DUPONT COMPOSITE RINGS | Jan 31, 1996 | Substantially Equivalent |
| K954485 | 6.5MM SOLID CANCELLOUS BONE SCREW | Oct 31, 1995 | Substantially Equivalent |
| K954069 | ACE CERVICAL TRACTION HALOZS, TONGS & PINS | Oct 12, 1995 | Substantially Equivalent |
| K950618 | ACE SUPRACONDYLAR PLATE | May 10, 1995 | Substantially Equivalent |
| K933968 | ACE PELVIC STABILIZER | Jun 16, 1994 | Substantially Equivalent |
| K931652 | ACE 6.5 MM BONE SCREW | Apr 28, 1994 | Substantially Equivalent for Some Indications |
| K930592 | ACE UNIVERSAL RECONSTRUCTION PLATE | Jul 26, 1993 | Substantially Equivalent |
| K912598 | ACE CORTICAL BONE SCREW | Nov 27, 1991 | Substantially Equivalent for Some Indications |
| K914858 | ACE OPEN-BACK HALO RING | Nov 21, 1991 | Substantially Equivalent |