MOA BONE / M-SPHERE
FDA 510(k) clearance K972143 · decided 1997-10-16
Clearance details
- K-number
- K972143
- Device name
- MOA BONE / M-SPHERE
- Applicant
- Iop, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-06-06
- Decision date
- 1997-10-16
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- HPZ
- Device class
- 2
- Regulation number
- 886.3320
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Costa Mesa, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EZYPOR (K212741) | Fci (France Chirurgie Instrumentation) Sas | 2022-06-24 |
| DURETTE OCULAR IMPLANT (K123764) | Oculo-Plastik, Inc. | 2013-01-31 |
| BIOCERAMIC ORBITAL IMPLANT, ORBTEX (K110554) | Ceramisys, Ltd. | 2011-11-02 |
| SILICONE SPHERES (K112176) | Oculo Plastik, Inc. | 2011-09-15 |
| ORBITAL RECONSTRUCTIVE IMPLANT II (K083342) | Evera Medical, Inc. | 2009-03-12 |
| EYE SPHERES (K082850) | Product and Educational Services, LLC | 2009-02-27 |
| DURETTE IMPLANT (K073293) | Oculo Plastik, Inc. | 2008-03-19 |
| MEDPOR ATTRACTOR IMPLANT (K071335) | Porex Surgical, Inc. | 2007-08-08 |
| ORBITAL RECONSTRUCTIVE IMPLANT (K070130) | Becker & Associates Consulting, Inc. | 2007-04-19 |
| ALPHASPHERE ORBITAL IMPLANT (K053298) | Hydron Pty Limited | 2006-05-09 |
| MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM (K040851) | Porex Surgical, Inc. | 2004-07-16 |
| EYE SPHERE IMPLANTS (K040689) | Oculo Plastik, Inc. | 2004-06-10 |
Recalls involving this device
No recalls on record reference this clearance.