Instrument Makar, Inc.
Okemos, MI, US
Instrument Makar, Inc. appears in FDA device records in Okemos, MI. FDA records list 28 510(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
- 28
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 28 510(k) clearances for Instrument Makar, Inc. between 1979 and 2000. The busiest year on record is 1983, with 3. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1980 | 2 |
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 3 |
| 1985 | 1 |
| 1988 | 1 |
| 1989 | 3 |
| 1990 | 1 |
| 1991 | 3 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 3 |
| 1996 | 2 |
| 1997 | 2 |
| 1998 | 1 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K002600 | LITWIN CRUICATE ANCHOR | MBI | Substantially Equivalent | |
| K980999 | ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT | JWH | Substantially Equivalent | |
| K963396 | BIOSPHERE SUTURE ANCHOR | MAI | Substantially Equivalent | |
| K964364 | DISPOSABLE APRON | LYU | Substantially Equivalent | |
| K955835 | FLUID BARRIER BOOT KNEE & ANKLE-HIGH | FXP | Substantially Equivalent | |
| K960555 | BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR | MAI | Substantially Equivalent | |
| K943249 | BIOABSORBABLE INTERFERENCE SCREW | MAI | Substantially Equivalent | |
| K944062 | LAPRASCOPIC GRASPER | GCS | Substantially Equivalent | |
| K942828 | MAKAR FULL AND HALF FACE SHIELD | LYU | Substantially Equivalent | |
| K930980 | INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW | HWC | Substantially Equivalent for Some Indications | |
| K923841 | BONE SCREWS | HWC | Substantially Equivalent | |
| K912021 | MAKAR MINI CANNULATED CANCELLOUS SCREWS | HWC | Substantially Equivalent | |
| K910723 | BIODEGRADABLE SURGICAL STAPLE | JDR | Substantially Equivalent | |
| K905365 | INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM | KYZ | Substantially Equivalent | |
| K902854 | GRAVITY ASSIST | KYZ | Substantially Equivalent | |
| K890973 | STRAIGHT PADDLE SURGICAL CAUTERY ELECTRODE BLADE | JOS | Substantially Equivalent | |
| K890972 | HOOK TIP SURGICAL CAUTERY ELECTRODE BLADE | JOS | Substantially Equivalent | |
| K885311 | MENISCUS MENDER II LOOP | HWQ | Substantially Equivalent | |
| K882407 | BOW & ARROW DRILL GUIDE | LXI | Substantially Equivalent | |
| K853597 | INSTRUMENT MAKAR DISPOSALBE LOOP | KDC | Substantially Equivalent | |
| K832978 | MENISCAL SUTURE GUN | GDF | Substantially Equivalent | |
| K830456 | STAPLE INSERTER-EXTRACTOR FOR ARTHROS | HXJ | Substantially Equivalent | |
| K830455 | STAPLES DESIGNED FOR ARTHROSCOPIC SURG | JDR | Substantially Equivalent | |
| K821847 | I.M. ARTHROSCOPE | HRX | Substantially Equivalent | |
| K810720 | I.M. SCALPEL HANDLE | GDZ | Substantially Equivalent | |
| K800444 | GOLDEN RETRIEVERS OR SILVER RETRIEVERS | HXB | Substantially Equivalent | |
| K800177 | I.M. BLADES | GDX | Substantially Equivalent | |
| K790674 | THE SURGICAL ASSISTANT | FWZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LYUAccessory, Surgical Apparel
- HRXArthroscope
- FXPCover, Shoe, Operating-Room
- JOSElectrode, Electrosurgical
- GCSEndoscope, Battery-Powered And Accessories
- MAIFastener, Fixation, Biodegradable, Soft Tissue
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- LXIGuide, Drill, Ligament
- GDFGuide, Needle, Surgical
- GDZHandle, Scalpel
- KDCInstrument, Surgical, Disposable
- FWZOperating Room Accessories Table Tray
- HWQPasser
- HXBProbe
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- GDXScalpel, One-Piece
- HWCScrew, Fixation, Bone
- HXJStaple Driver
- JDRStaple, Fixation, Bone
- KYZSyringe, Irrigating (Non Dental)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Instrument Makar, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Instrument Makar, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain