Company ยท US
Integrated Orbital Implants, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2001. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 7, 2001 | K003338 | BIO-EYE II ORBITAL IMPLANT Integrated Orbital Implants, Inc. | HPZ |
| Apr 10, 2000 | K000151 | PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE Integrated Orbital Implants, Inc. | MQU |
| Dec 28, 1998 | K982562 | BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER Integrated Orbital Implants, Inc. | HPZ |
| Feb 4, 1998 | K974203 | PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM Integrated Orbital Implants, Inc. | MQU |
| Aug 24, 1989 | K891137 | MOTILITY ORBITAL IMPLANT Integrated Orbital Implants, Inc. | HPZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2011 | Integrated Orbital Implants Inc Product Brand Name: Coated Bio-Eye Orbital Implant w/Conformer.
Product Generic Name: Implant, Eye Sphere Wrap, Implant, Orbital.
Model Number: I0016C, I0018C, I0020C, I0022C, I0024C.
Description o Terminated |
HPZ | K003338 |
| Aug 26, 2010 | Integrated Orbital Implants Inc Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer Terminated |
HPZ | K982562 |
| Feb 7, 2007 | Integrated Orbital Implants Inc Perry-Kolberg Titanium Motility/Support System (Threaded Sleeve and Flat Peg), Model Number 100045
The threaded sleeve and flat peg are two components of the P-K Titanium Motility/Support Syste Terminated |
MQU | K974203 |
| Oct 4, 2006 | Integrated Orbital Implants Inc Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S Terminated |
HPZ | K982562 |