The following data is part of a premarket notification filed by Jerome Medical with the FDA for Resolve Open Back Halo Rings.
| Device ID | K051918 |
| 510k Number | K051918 |
| Device Name: | RESOLVE OPEN BACK HALO RINGS |
| Classification | Tong, Skull For Traction |
| Applicant | JEROME MEDICAL 305 HARPER DR. Moorestown, NJ 08057 |
| Contact | Bernie Tatro |
| Correspondent | Bernie Tatro JEROME MEDICAL 305 HARPER DR. Moorestown, NJ 08057 |
| Product Code | HAX |
| CFR Regulation Number | 882.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-15 |
| Decision Date | 2005-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05690977370524 | K051918 | 000 |
| 05690977308626 | K051918 | 000 |
| 05690977307599 | K051918 | 000 |
| 05690977305922 | K051918 | 000 |
| 05690977305915 | K051918 | 000 |
| 05690977223370 | K051918 | 000 |
| 05690977197404 | K051918 | 000 |
| 05690977197336 | K051918 | 000 |
| 05690977197329 | K051918 | 000 |
| 05690977197312 | K051918 | 000 |
| 05690977193192 | K051918 | 000 |
| 05690977192348 | K051918 | 000 |
| 05690977308633 | K051918 | 000 |
| 05690977308640 | K051918 | 000 |
| 05690977308657 | K051918 | 000 |
| 05690977368972 | K051918 | 000 |
| 05690977343306 | K051918 | 000 |
| 05690977343283 | K051918 | 000 |
| 05690977343269 | K051918 | 000 |
| 05690977334960 | K051918 | 000 |
| 05690977326200 | K051918 | 000 |
| 05690977319035 | K051918 | 000 |
| 05690977308695 | K051918 | 000 |
| 05690977308688 | K051918 | 000 |
| 05690977308671 | K051918 | 000 |
| 05690977308664 | K051918 | 000 |
| 05690977165335 | K051918 | 000 |