The following data is part of a premarket notification filed by Newclip Technics with the FDA for Distal Radius Locking Plating System.
| Device ID | K061917 |
| 510k Number | K061917 |
| Device Name: | DISTAL RADIUS LOCKING PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | NEWCLIP TECHNICS 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb NEWCLIP TECHNICS 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-06 |
| Decision Date | 2006-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700569613266 | K061917 | 000 |
| 03700569601379 | K061917 | 000 |
| 03700569601362 | K061917 | 000 |
| 03700569601355 | K061917 | 000 |
| 03700569601348 | K061917 | 000 |
| 03700569612894 | K061917 | 000 |
| 03700569612887 | K061917 | 000 |
| 03700569612115 | K061917 | 000 |
| 03700569602345 | K061917 | 000 |
| 03700569602321 | K061917 | 000 |
| 03700569601232 | K061917 | 000 |
| 03700569601225 | K061917 | 000 |
| 03700569601218 | K061917 | 000 |
| 03700569601201 | K061917 | 000 |
| 03700569601195 | K061917 | 000 |
| 03700569601386 | K061917 | 000 |
| 03700569601393 | K061917 | 000 |
| 03700569601409 | K061917 | 000 |
| 03700569613242 | K061917 | 000 |
| 03700569613228 | K061917 | 000 |
| 03700569613204 | K061917 | 000 |
| 03700569613181 | K061917 | 000 |
| 03700569613167 | K061917 | 000 |
| 03700569613143 | K061917 | 000 |
| 03700569613129 | K061917 | 000 |
| 03700569613105 | K061917 | 000 |
| 03700569601584 | K061917 | 000 |
| 03700569601577 | K061917 | 000 |
| 03700569601560 | K061917 | 000 |
| 03700569601553 | K061917 | 000 |
| 03700569601546 | K061917 | 000 |
| 03700569601416 | K061917 | 000 |
| 03700569601188 | K061917 | 000 |