The following data is part of a premarket notification filed by Gs Medical Co., Ltd. with the FDA for Gss Pedicle Screw System.
| Device ID | K053573 |
| 510k Number | K053573 |
| Device Name: | GSS PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | GS MEDICAL CO., LTD. 222-13 GURO-DONG, GURO-GU ROOM NO. 703 Seoul, KR 152-848 |
| Contact | Sun-eun Jung |
| Correspondent | Sun-eun Jung GS MEDICAL CO., LTD. 222-13 GURO-DONG, GURO-GU ROOM NO. 703 Seoul, KR 152-848 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-22 |
| Decision Date | 2006-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806378329758 | K053573 | 000 |
| 08806162175394 | K053573 | 000 |
| 08806162175387 | K053573 | 000 |
| 08806162175370 | K053573 | 000 |
| 08806162175189 | K053573 | 000 |
| 08806162175158 | K053573 | 000 |
| 08806162175141 | K053573 | 000 |
| 08806162175134 | K053573 | 000 |
| 08806162175127 | K053573 | 000 |
| 08806162175110 | K053573 | 000 |
| 08806162175004 | K053573 | 000 |
| 08806162174991 | K053573 | 000 |
| 08806162174984 | K053573 | 000 |
| 08806162174977 | K053573 | 000 |
| 08806162174960 | K053573 | 000 |
| 08806162174953 | K053573 | 000 |
| 08806162174946 | K053573 | 000 |
| 08806162174939 | K053573 | 000 |
| 08806162175400 | K053573 | 000 |
| 08806162175417 | K053573 | 000 |
| 08806162175479 | K053573 | 000 |
| 08806162175196 | K053573 | 000 |
| 08806162175172 | K053573 | 000 |
| 08806162175165 | K053573 | 000 |
| 08806162175721 | K053573 | 000 |
| 08806162175714 | K053573 | 000 |
| 08806162175707 | K053573 | 000 |
| 08806162175691 | K053573 | 000 |
| 08806162175684 | K053573 | 000 |
| 08806162175677 | K053573 | 000 |
| 08806162175660 | K053573 | 000 |
| 08806162175653 | K053573 | 000 |
| 08806162175646 | K053573 | 000 |
| 08806162175455 | K053573 | 000 |
| 08806162175448 | K053573 | 000 |
| 08806162175431 | K053573 | 000 |
| 08806162175424 | K053573 | 000 |
| 08806162174922 | K053573 | 000 |