FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ISOLA SPINAL SYSTEM
K Number: K980485
·
Decision Oct 21, 1998
Classifications
1
FEI Numbers
342
Registration Numbers
342
Same Product Code
302
Applicant Total
41
Review Days
254
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Basic Information
- Device Name
- ISOLA SPINAL SYSTEM
- K Number
- K980485
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acromed Corp.
- Date Received
- February 9, 1998
- Decision Date
- October 21, 1998
- Product Code
- MNI
- 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 |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | FDA class 2 | Orthopedic |
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Other Clearances by Acromed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K981714 | TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM | Jun 30, 1998 | Substantially Equivalent |
| K981113 | PEDIATRIC PRC | May 29, 1998 | Substantially Equivalent |
| K981274 | ACROMED TIMX PLATE BASED LOW BACK SYSTEM | Apr 29, 1998 | Substantially Equivalent |
| K980228 | UNIVERSITY PLATE ANTERIOR SYSTEM | Apr 14, 1998 | Substantially Equivalent for Some Indications |
| K974757 | KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS | Mar 5, 1998 | Substantially Equivalent for Some Indications |
| K972718 | M-2 ANTERIOR PLATE SYSTEM | Oct 1, 1997 | Substantially Equivalent for Some Indications |
| K971248 | KANEDA SR ANTERIOR SPINAL SYSTEM | Jun 11, 1997 | Substantially Equivalent for Some Indications |
| K970955 | ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM | Jun 11, 1997 | Substantially Equivalent for Some Indications |
| K970950 | EASY ROD | Jun 3, 1997 | Substantially Equivalent |
| K965102 | ACROMED PEDICLE SCREW | May 8, 1997 | Substantially Equivalent |