EU Manufacturer
๐บ๐ธ United States
Active
Integrity Implants Inc.
SRN: US-MF-000009805
ยท
Hiatt Drive 354, 34418 Palm Beach Gardens, United States
Basic UDI-DIs
249
Total Devices
291
On Market
236
Off Market
55
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
6
Basic Information
- Address
- Hiatt Drive 354, 34418 Palm Beach Gardens, United States
- [email protected]
- Phone
- +1 561 529 3861
- Website
- www.accelusinc.com
Regulatory Overview
Regulation
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Eu Mdd
241
Eu Mdr
8
Classification
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Eu Md Class 1
211
Eu Md Class 2b
38
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | G1 004094 0002 | TรV SรD Product Service GmbH | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 6 countries across Europe.
๐จ๐พ Cyprus
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ฎ๐น Italy
๐ต๐น Portugal
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| 0 Degree Shaver and Distractor Tray | EU MDR | Eu Md Class 1 | On Market | 0 |
| 9ยฐ and 15ยฐ Distractor Tray | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ancillary Instrument Tray, FH7 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Backup Fixed T-Handle | EU MDR | Eu Md Class 1 | On Market | 0 |
| Depth Stop, FH7 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Dilator Handle, FH7 MIS | EU MDR | Eu Md Class 1 | On Market | 0 |
| Dilator Impactor, FH7 ENDO | EU MDR | Eu Md Class 1 | On Market | 0 |
| Dilator Impactor, FH7 MIS | EU MDR | Eu Md Class 1 | On Market | 0 |
| ENDO Access Tray, FH7 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Expandable Trial Insert Tray, FH7 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Fixed Hudson T-Handle | EU MDR | Eu Md Class 1 | On Market | 0 |
| Fixed Small Inline Handle | EU MDR | Eu Md Class 1 | On Market | 0 |
| Fixed Small Teardrop Handle | EU MDR | Eu Md Class 1 | On Market | 0 |
| FlareHawk Guide Pin Tray | EU MDR | Eu Md Class 1 | On Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | On Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | On Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | On Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | On Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | On Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | On Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | On Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |
| FlareHawk Interbody Fusion System | EU MDD | Eu Md Class 1 | Off Market | 0 |