FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOA BONE / M-SPHERE
K Number: K972143
·
Decision Oct 16, 1997
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
38
Applicant Total
9
Review Days
132
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Basic Information
- Device Name
- MOA BONE / M-SPHERE
- K Number
- K972143
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.3320
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Iop, Inc.
- Date Received
- June 6, 1997
- Decision Date
- October 16, 1997
- Product Code
- HPZ
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HPZ | Implant, Eye Sphere | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HPZ), ordered by most recent decision date.
EZYPOR
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SILICONE SPHERES
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ORBITAL RECONSTRUCTIVE IMPLANT II
FDA 510(k)
FDA Class 2
·Ophthalmic
EYE SPHERES
FDA 510(k)
FDA Class 2
·Ophthalmic
Other Clearances by Iop, Inc.
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|---|---|---|---|
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| K062252 | MOLTENO3 | Sep 27, 2006 | Substantially Equivalent |
| K053622 | SURGISIS OCULAR GRAFT | Mar 15, 2006 | Substantially Equivalent |
| K010852 | OSMED TISSUE EXPANDER | Aug 13, 2001 | Substantially Equivalent |
| K003646 | SUTUREGROOVE WEIGHT SIZING SET | Feb 22, 2001 | Unknown |
| K994289 | SUTUREGROOVE | Apr 17, 2000 | Substantially Equivalent |
| K902489 | MODIFIED MOLTENO(TM) IMPLANTS | Aug 14, 1990 | Substantially Equivalent |
| K890598 | MOLTENO IMPLANT | Feb 27, 1989 | Substantially Equivalent |