Regeneration Technologies, Inc.: FDA clearances and approvals
Regeneration Technologies, Inc. has 11 FDA 510(k) clearances (first 2005, latest 2008), across 4 product codes in 2 review panels. Median 510(k) review time: 75 days. openFDA lists 27 product recalls by a recalling firm named Regeneration Technologies, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 5 | 5 |
| HWC | Screw, Fixation, Bone | 4 | 4 |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | 1 | 1 |
| NUN | Bone Grafting Material, Human Source | 1 | 1 |
Review panels
- Orthopedic (10)
- Dental (1)
Most recent Regeneration Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080418 | REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST | NUN | 2008-04-30 | 75 |
| K072238 | BIOSET XCH | MQV | 2008-01-25 | 165 |
| K072327 | CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON | MQV | 2007-10-24 | 65 |
| K063584 | STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937 | HWC | 2007-05-09 | 159 |
| K060180 | BIOSET XC | MBP | 2006-09-06 | 226 |
| K060253 | STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST. | HWC | 2006-02-23 | 22 |
| K052405 | STERLING INTERFERENC SCREW HT | HWC | 2005-11-16 | 76 |
| K051615 | STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES | MQV | 2005-08-15 | 59 |
| K050767 | STERLING INTERFERENCE SCREW ST | HWC | 2005-06-09 | 76 |
| K043421 | OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC | MQV | 2005-02-16 | 65 |
1 earlier clearances. See the full list in Caduvo.
Recalls
27 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2005-10-14.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Regeneration Technologies, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Regeneration Technologies, Inc. have?
Regeneration Technologies, Inc. has 11 FDA 510(k) clearances (first 2005, latest 2008), across 4 product codes in 2 review panels.
How long does FDA take to clear Regeneration Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Regeneration Technologies, Inc.'s cleared 510(k)s is 75 days.
What devices does Regeneration Technologies, Inc. make?
Its most frequent FDA product codes are MQV (Filler, Bone Void, Calcium Compound, 5); HWC (Screw, Fixation, Bone, 4); MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor), 1).
Has Regeneration Technologies, Inc. had device recalls?
openFDA lists 27 product recalls in 2 recall events by a recalling firm whose name matches Regeneration Technologies, Inc; the most recent began 2005-10-14. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 11 Regeneration Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQV, Regeneration Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.