The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Cervical Spacer System.
| Device ID | K141129 |
| 510k Number | K141129 |
| Device Name: | EXACTECH CERVICAL SPACER SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | EXACTECH, INC. 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Contact | Meredith May Ms, Rac |
| Correspondent | Meredith May Ms, Rac EXACTECH, INC. 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-01 |
| Decision Date | 2014-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996184373 | K141129 | 000 |
| 00840996184250 | K141129 | 000 |
| 00840996184267 | K141129 | 000 |
| 00840996184274 | K141129 | 000 |
| 00840996184281 | K141129 | 000 |
| 00840996184298 | K141129 | 000 |
| 00840996184304 | K141129 | 000 |
| 00840996184311 | K141129 | 000 |
| 00840996184328 | K141129 | 000 |
| 00840996184335 | K141129 | 000 |
| 00840996184342 | K141129 | 000 |
| 00840996184359 | K141129 | 000 |
| 00840996184366 | K141129 | 000 |
| 00840996184243 | K141129 | 000 |