The following data is part of a premarket notification filed by Depuy Synthes Companies Of Johnson & Johnson with the FDA for Depuy Synthes Injectable Polymer System (ips).
| Device ID | K141385 |
| 510k Number | K141385 |
| Device Name: | DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) |
| Classification | Fastener, Plate, Cranioplasty |
| Applicant | DEPUY SYNTHES COMPANIES OF JOHNSON & JOHNSON 1230 WILSON DRIVE West Chester, PA 19380 |
| Contact | Jeffrey Dow |
| Correspondent | Jeffrey Dow DEPUY SYNTHES COMPANIES OF JOHNSON & JOHNSON 1230 WILSON DRIVE West Chester, PA 19380 |
| Product Code | HBW |
| CFR Regulation Number | 882.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-27 |
| Decision Date | 2015-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98053055501S0 | K141385 | 000 |
| H98080555001S0 | K141385 | 000 |
| H98080552001S0 | K141385 | 000 |
| H98080551001S0 | K141385 | 000 |
| H98080550501S0 | K141385 | 000 |
| H9805305540 | K141385 | 000 |
| H98053055301S0 | K141385 | 000 |
| H9805305510 | K141385 | 000 |