ACE CUSTOM SURGICAL PACK— 510(k) K922648
UnknownAce Surgical Supply Co., Inc.
FDA 510(k) clearance K922648 for ACE CUSTOM SURGICAL PACK, Unknown on 1993-03-20. Applicant: Ace Surgical Supply Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Ace Surgical Supply Co., Inc.
- Product code
- Code LRO
- Device class
- Class 2
- Regulation
- 21 CFR 878.4370
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Brockton, MA, US
Recent devices under product code LRO
view allMore clearances from Ace Surgical Supply Co., Inc.
view all- K093518 — ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM
- K092594 — ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX
- K073343 — ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX
- K080074 — ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX
- K061397 — ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M
Adverse events under product code LRO
product code LRO- Injury
- 975
- Malfunction
- 14,038
- Other
- 2
- Total
- 15,015
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.