The following data is part of a premarket notification filed by Dinkler Surgical Devices, Inc. with the FDA for Limited Artifact Skull Pin, Model 0107.
| Device ID | K073163 |
| 510k Number | K073163 |
| Device Name: | LIMITED ARTIFACT SKULL PIN, MODEL 0107 |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | DINKLER SURGICAL DEVICES, INC. 174 LOOKOUT DRIVE Dayton, OH 45419 |
| Contact | Charles E Dinkler Ii |
| Correspondent | Charles E Dinkler Ii DINKLER SURGICAL DEVICES, INC. 174 LOOKOUT DRIVE Dayton, OH 45419 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-09 |
| Decision Date | 2008-02-28 |
| Summary: | summary |