Data / Medical devices / United States / Integrated Orbital Implants, Inc.
Integrated Orbital Implants, Inc.: FDA-registered device maker in San Diego, CA, United States, 3 510(k) clearances
Integrated Orbital Implants, Inc. is registered with the FDA (registration 2027377) in San Diego, CA, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 28, 1998. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2027377
- FEI number
- 3009688114
- Address
- 11230 Sorrento Valley Rd Ste 135, San Diego, CA, United States, 92121
- Owner or operator
- INTEGRATED ORBITAL IMPLANTS INC (2027377)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- December 11, 2006
- Registered through
- 2027
- Brand names listed
- IMPLANT, EYE SPHERE, Needle, ophthalmic suturing, OCULAR PEG, Sterile Bio-eye Ha implant & conf., THREADED SLEEVE DRIVER, THREADED SLEEVE WRENCH
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Conformer, Ophthalmic | HQN | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Implant, Eye Sphere | HPZ | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Needle, Ophthalmic Suturing | HNM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Ocular Peg | MQU | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Screwdriver, Surgical | LRZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 28, 1998 | K982562 | BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER | HPZ | Substantially Equivalent | Integrated Orbital Implants, Inc. | accessdata.fda.gov |
| February 4, 1998 | K974203 | PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM | MQU | Substantially Equivalent | Integrated Orbital Implants, Inc. | accessdata.fda.gov |
| August 24, 1989 | K891137 | MOTILITY ORBITAL IMPLANT | HPZ | Substantially Equivalent | Integrated Orbital Implants, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 20, 2011 | 58877 | Not yet classified | Terminated | 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 of the product: The Coat | The recall was initiated because Integrated Orbital Implants has confirmed certain lots of the Coated Bio-Eye were manufactured without expiration dating visible on the packaging. All unlabeled product is currently beyond its expiration date. | accessdata.fda.gov |
| June 7, 2010 | 56329 | Not yet classified | Terminated | Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer | Integrated Orbital Implants, Inc. has initiated a recall of it's Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer due to a labeling issue in which the expiration date of the product was omitted. | accessdata.fda.gov |
| December 20, 2006 | 37139 | Not yet classified | Terminated | 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 System. The threaded sleeve is a | The threads on the threaded sleeve were manufactured with left-handed threads, requiring a modification to the surgical technique for proper insertion. Failure to properly identify the affected components and apply the modified insertion technique will result in an inability to insert the sleeve into the implant. | accessdata.fda.gov |
| February 27, 2006 | 36298 | Not yet classified | Terminated | Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S | The end label on the outer box was mislabeled on 9 of a 10 unit lot. The end label says ''22 mm'' and the implants are actually ''20 mm''. The main label on the cardboard box applied by the contract packager is correct in identifying the product as ''20 mm''. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Eye Sphere
- All makers of Needle, Ophthalmic Suturing
- All makers of Screwdriver, Surgical
- All makers of Conformer, Ophthalmic
- All makers of Ocular Peg
Updated June 22, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.