The following data is part of a premarket notification filed by Gpc Medical Ltd with the FDA for Gpc Bone Plaes And Bone Screw & Gpc Dhs/dcs Plate System.
| Device ID | K092493 |
| 510k Number | K092493 |
| Device Name: | GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | GPC MEDICAL LTD M-BLOCK, DDA LSC, Vikas Puri, New Delhi, IN 110018 |
| Contact | Vikas Narang |
| Correspondent | Vikas Narang GPC MEDICAL LTD M-BLOCK, DDA LSC, Vikas Puri, New Delhi, IN 110018 |
| Product Code | HRS |
| Subsequent Product Code | HWC |
| Subsequent Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-14 |
| Decision Date | 2010-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08905892066450 | K092493 | 000 |
| 08905892062049 | K092493 | 000 |
| 08905892062032 | K092493 | 000 |
| 08905892062025 | K092493 | 000 |
| 08905892062018 | K092493 | 000 |
| 08905892062001 | K092493 | 000 |
| 08905892061998 | K092493 | 000 |
| 08905892061981 | K092493 | 000 |
| 08905892061974 | K092493 | 000 |
| 08905892061967 | K092493 | 000 |
| 08905892061950 | K092493 | 000 |
| 08905892061943 | K092493 | 000 |
| 08905892061936 | K092493 | 000 |
| 08905892061929 | K092493 | 000 |
| 08905892061912 | K092493 | 000 |
| 08905892062056 | K092493 | 000 |
| 08905892062063 | K092493 | 000 |
| 08905892062070 | K092493 | 000 |
| 08905892066443 | K092493 | 000 |
| 08905892066436 | K092493 | 000 |
| 08905892066429 | K092493 | 000 |
| 08905892062186 | K092493 | 000 |
| 08905892062179 | K092493 | 000 |
| 08905892062162 | K092493 | 000 |
| 08905892062155 | K092493 | 000 |
| 08905892062148 | K092493 | 000 |
| 08905892062131 | K092493 | 000 |
| 08905892062124 | K092493 | 000 |
| 08905892062117 | K092493 | 000 |
| 08905892062100 | K092493 | 000 |
| 08905892062094 | K092493 | 000 |
| 08905892062087 | K092493 | 000 |
| 08905892061905 | K092493 | 000 |