Innovasive Devices, Inc.
Hopkinton, MA, US
Innovasive Devices, Inc. appears in FDA device records in Hopkinton, MA. FDA records list 34 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 34
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 34 510(k) clearances for Innovasive Devices, Inc. between 1993 and 2000. The busiest year on record is 1997, with 9. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1994 | 3 |
| 1995 | 3 |
| 1996 | 2 |
| 1997 | 9 |
| 1998 | 9 |
| 1999 | 6 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K994269 | TITAN RC TACK | MAI | Substantially Equivalent | |
| K993975 | ABSOLUTE ABSORBABLE INTERFERENCE SCREW | HWC | Substantially Equivalent | |
| K992458 | RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454 | MBI | Substantially Equivalent | |
| K992377 | RC TACK | MBI | Substantially Equivalent | |
| K990454 | BIO-INTERFERENCE SCREW | HWC | Substantially Equivalent | |
| K984490 | SUTURELESS ANCHOR | MAI | Substantially Equivalent | |
| K983560 | INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER | MBI | Substantially Equivalent | |
| K983056 | INNOVASIVE TIBIAL FASTENER | MBI | Substantially Equivalent | |
| K981340 | INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM | MAI | Substantially Equivalent | |
| K981193 | INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER | MBI | Substantially Equivalent | |
| K980681 | INNOVASIVE DEVICES MENISCAL SCREW | HWC | Substantially Equivalent | |
| K980491 | INNOVASIVE LINX TIBIAL LIGAMENT FASTENER | MBI | Substantially Equivalent | |
| K980334 | INNOVASIVE 10MM LINX HT LIGAMENT FASTENER | MBI | Substantially Equivalent | |
| K973874 | ACL CLIP-IN PLATE | MBI | Substantially Equivalent | |
| K974049 | INNOVASIVE LINX BT 10MM LIGAMENT FASTENER | MBI | Substantially Equivalent | |
| K973381 | BIOROC EZ SUTURE BONE FASTENER | MAI | Substantially Equivalent | |
| K973323 | ACL CLIP-IN | MBI | Substantially Equivalent | |
| K973313 | INNOVASIVE DEVICES Y-KNOT SUTURE CLIP | OCW | Substantially Equivalent | |
| K972438 | INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENER | MBI | Substantially Equivalent | |
| K972356 | INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENER | MBI | Substantially Equivalent | |
| K971922 | INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER | MBI | Substantially Equivalent | |
| K970423 | INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICE | MBI | Substantially Equivalent | |
| K970316 | INNOVASIVE 8MM LIGAMENT FASTENER | MBI | Substantially Equivalent | |
| K970089 | INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER | MBI | Substantially Equivalent | |
| K964945 | INNOVASIVE DEVICES ROTATOR CUFF FASTNER | MBI | Substantially Equivalent | |
| K963402 | INNOVASIVE 2.8MM ROC SUTURE BONE FASTENER AND 3.5MM ROC SUTURE BONE FASTENER | MBI | Substantially Equivalent | |
| K954338 | INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER | MBI | Substantially Equivalent for Some Indications | |
| K952237 | INNOVASICE 2.8MM & 3.5MM ROC SUTURE BONE FASTENER | MBI | Substantially Equivalent for Some Indications | |
| K951565 | INNOVASIVE DEVICES ROTATOR CUFF FASTENER | MBI | Substantially Equivalent | |
| K944831 | INNOVASIVE 1.9MM, 2.8MM, 3.5MM, 4.5MM ROC SUTURE BONE FASTENER | MBI | Substantially Equivalent for Some Indications | |
| K935321 | INNOVASIVE SUTURE BONE FASTENER WITH SUTURE | JDR | Substantially Equivalent | |
| K941273 | INNOVASIVE ARTHROSCOPIC ROC SUTURE BONE FASTENER | HRX | Substantially Equivalent | |
| K934338 | INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION | GCJ | Substantially Equivalent | |
| K924034 | MINVASIVE SUTURE BONE FASTENER | JDR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain