Motility Orbital Implant
FDA 510(k) K891137 · Integrated Orbital Implants, Inc.
510(k) numberK891137
Submission
- Device name
- Motility Orbital Implant
- Applicant
- Integrated Orbital Implants, Inc.
La Jolla, CA, US - Received
- March 3, 1989
- Decision date
- August 24, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HPZ – Implant, Eye Sphere
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3320
- Specialty
- Ophthalmic
- Implant
- Yes
Other 510(k)s with product code HPZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212741 | EzyporHPZ · Traditional | Fci (France Chirurgie Instrumentation) Sas | 06/24/2022SE |
| K123764 | Durette Ocular ImplantHPZ · Traditional | Oculo-Plastik, Inc. | 01/31/2013SE |
| K110554 | Bioceramic Orbital Implant, OrbtexHPZ · Traditional | Ceramisys, Ltd. | 11/02/2011SE |
| K112176 | Silicone SpheresHPZ · Special | Oculo Plastik, Inc. | 09/15/2011SE |
| K083342 | Orbital Reconstructive Implant IIHPZ · Traditional | Evera Medical, Inc. | 03/12/2009SE |
| K082850 | Eye SpheresHPZ · Traditional | Product and Educational Services, LLC | 02/27/2009SE |
| K073293 | Durette ImplantHPZ · Traditional | Oculo Plastik, Inc. | 03/19/2008SE |
| K071335 | Medpor Attractor ImplantHPZ · Traditional | Porex Surgical, Inc. | 08/08/2007SE |
| K070130 | Orbital Reconstructive ImplantHPZ · Traditional | Becker & Associates Consulting, Inc. | 04/19/2007SE |
| K053298 | Alphasphere Orbital ImplantHPZ · Traditional | Hydron Pty Limited | 05/09/2006SE |
More from Hydron Pty Limited
| 510(k) | Device | Decision |
|---|---|---|
| K003338 | Bio-Eye II Orbital ImplantHPZ · Traditional | 02/07/2001SE |
| K000151 | Perry-Kolberg (PK) Ha-Coated Titanium SleeveMQU · Traditional | 04/10/2000SE |
| K982562 | Bio-Eye Hydroxyapatite Ocular Impland and ConformerHPZ · Traditional | 12/28/1998SE |
| K974203 | Perry-Kolberg (PK) Titanium Motility/Support SystemMQU · Traditional | 02/04/1998SE |
Questions and answers
When was Motility Orbital Implant cleared by the FDA?
Motility Orbital Implant (K891137) received a 510(k) decision of Substantially Equivalent on August 24, 1989, 174 days after the submission was received.
What is the product code of K891137?
The FDA product code is HPZ – Implant, Eye Sphere, a Class II (moderate risk) device regulated under 21 CFR 886.3320.