The following data is part of a premarket notification filed by Holter-hausner Intl. with the FDA for Tendon Rod Model Or41po3-6.
| Device ID | K781943 |
| 510k Number | K781943 |
| Device Name: | TENDON ROD MODEL OR41PO3-6 |
| Classification | Prosthesis, Tendon, Passive |
| Applicant | HOLTER-HAUSNER INTL. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HXA |
| CFR Regulation Number | 888.3025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-17 |
| Decision Date | 1978-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420130693 | K781943 | 000 |
| 00840420188380 | K781943 | 000 |
| 00840420188397 | K781943 | 000 |
| 00840420188403 | K781943 | 000 |
| 00840420188410 | K781943 | 000 |
| 00840420121851 | K781943 | 000 |
| 00840420121868 | K781943 | 000 |
| 00840420121875 | K781943 | 000 |
| 00840420121882 | K781943 | 000 |
| 00840420130662 | K781943 | 000 |
| 00840420130679 | K781943 | 000 |
| 00840420130686 | K781943 | 000 |
| 00840420188373 | K781943 | 000 |